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Xarelto rivaroxaban 07/01 To reduce the risk of blood clots, deep vein

thrombosis (DVT), and pulmonary embolism (PE)

following knee or hip replacement surgery.

Press Release

Arcapta

Neohaler

indacaterol

inhalationpowder

07/01 For the long term, once-daily maintenance

bronchodilator treatment of airflow obstruction inpeople with chronic obstructive pulmonary disease

(COPD) including chronic bronchitis and/or

emphysema.

Press Release

Nulojix belatacept 06/15 To prevent acute rejection in adult patients who have

had a kidney transplant.

Press Release

Potiga ezogabine 06/10 For use as an add-on medication to treat seizures

associated with epilepsy in adults.

Press ReleaseDificid fidaxomicin 05/27 For the treatment of Clostridium difficile-associated

diarrhea (CDAD).

Press Release

Incivek telaprevir 05/23 To treat certain adults with chronic hepatitis C

infection.

Press Release

FDA Briefing on New Hepatitis C Drugs

Consumer Information on Hepatitis B and C

Edurant rilpivirine 05/20 For the treatment of HIV-1 infection in adults who

have never taken HIV therapy.

Press ReleaseVictrelis boceprevir 05/13 To treat certain adults with chronic hepatitis C.

Press Release

FDA Briefing on New Hepatitis C Drugs

Consumer Information on Hepatitis B and C

Tradjenta linagliptin 05/02 An adjunct to diet and exercise to improve glycemic

control in adults with type 2 diabetes mellitus.

Press Release

Zytiga abiraterone

acetate

04/28 In combination with prednisone (a steroid) to treat

patients with late-stage (metastatic) castration-

resistant prostate cancer who have received priordocetaxel (chemotherapy).

Press Release

Caprelsa vandetanib 04/06 To treat adult patients with late-stage (metastatic)

medullary thyroid cancer who are ineligible for

surgery and who have disease that is growing or

causing symptoms.

Press Release

Horizant gabapentin

enacarbil

04/06 A once-daily treatment for moderate-to-severe

restless legs syndrome (RLS).

Press Release

Yervoy ipilimumab 03/25 To treat patients with late-stage (metastatic)melanoma, the most dangerous type of skin cancer.

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=022406&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm261839.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm261839.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=022383&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=022383&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm261649.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=125288&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm259184.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm259184.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=022345&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm258834.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm258834.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=201699&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm257024.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm257024.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=201917&SearchType=BasicSearchhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ssLINK/ucm256299.htmhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ssLINK/ucm256299.htmhttp://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256753.htmhttp://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256753.htmhttp://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm151488.htmhttp://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm151488.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202022&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202022&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256087.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256087.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=202258&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm255390.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm255390.htmhttp://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256753.htmhttp://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256753.htmhttp://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm151488.htmhttp://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm151488.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=201280&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm253501.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm253501.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=202379&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=202379&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm253055.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm253055.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=022405&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=022405&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm250168.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm250168.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=022399&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=022399&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm250188.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm250188.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=125377&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=125377&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm250188.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=022399&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm250168.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=022405&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm253055.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=202379&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm253501.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=201280&SearchType=BasicSearchhttp://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm151488.htmhttp://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256753.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm255390.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=202258&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256087.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202022&SearchType=BasicSearchhttp://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm151488.htmhttp://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm256753.htmhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ssLINK/ucm256299.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=201917&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm257024.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=201699&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm258834.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=022345&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm259184.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=125288&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm261649.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=022383&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=022383&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm261839.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=022406&SearchType=BasicSearch

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Press Release

Gadavist gadobutrol 03/14 For use in patients undergoing magnetic resonance

imaging (MRI) of the central nervous system.

Press Release

Benlysta belimumab 03/9 To treat patients with active, autoantibody-positive

lupus (systemic lupus erythematosus) who arereceiving standard therapy, including corticosteroids,

antimalarials, immunosuppressives, and nonsteroidal

anti-inflammatory drugs.

Press Release

Daliresp roflumilast 02/28 To decrease the frequency of flare-ups

(exacerbations) or worsening of symptoms from

severe chronic obstructive pulmonary disease

(COPD).

Press Release

Edarbi

azilsartanmedoxomil 02/25 To treat high blood pressure (hypertension) in adults.Press Release

Viibryd vilazodone

hydrochloride

01/21 To treat major depressive disorder in adults.

Press Release

Natroba spinosad 01/18 For the treatment of head lice infestation in patients

ages 4 years and older.

Press Release

Datscan ioflupane i-123 01/14 An imaging drug used to assist in the evaluation of

adult patients with suspected Parkinsonian

syndromes (PS).

2012

No. Drug Name Active

Ingredient

Date What its used for

39. Fulyzaq crofelemer 12/31/12To treat HIV/AIDS patients whose diarrhea is not

caused by an infection from a virus, bacteria, or

parasite.

Press Release

38. Sirturo bedaquiline 12/28/12As part of combination therapy to treat adultswith multi-drug resistant pulmonary tuberculosis

(TB) when other alternatives are not available.

Press Release

37. Eliquis apixaban 12/28/12To reduce the risk of stroke and dangerous blood

clots (systemic embolism) in patients with atrial

fibrillation that is not caused by a heart valve

problem.

Press Release

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satfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=200796&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm244989.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=022522&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm246489.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=125370&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm247207.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=201277&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm1193237.htm

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36. Juxtapid lomitapide 12/21/12 To reduce low-density lipoprotein (LDL)

cholesterol, total cholesterol, apolipoprotein B,

and non-high-density lipoprotein (non-HDL)

cholesterol in patients with homozygous familial

hypercholesterolemia (HoFH).

Press Release

35. Gattex teduglutide 12/21/12 To treat adults with short bowel syndrome (SBS)

who need additional nutrition from intravenous

feeding (parenteral nutrition).

Press Release

34. Signifor pasereotide 12/14/12 To treat Cushings disease patients who cannot

be helped through surgery

Press Release

33. raxibacumab raxibacumab 12/14/12To treat inhalational anthrax, a form of the

infectious disease caused by breathing in the

spores of the bacterium Bacillus anthracis.

Press Release

32. Iclusig ponatinib 12/14/12 To treat adults with chronic myeloid leukemia

(CML) and Philadelphia chromosome positive

acute lymphoblastic leukemia (Ph+ ALL),

two rare blood and bone marrow diseases.

Press Release31. Cometriq cabozantinib 11/29/12 To treat medullary thyroid cancer that has

spread to other parts of the body

(metastasized).

Press Release

30. Xeljanz tofacitinib 11/6/12 To treat adults with moderately to severely

active rheumatoid arthritis (RA) who have

had an inadequate response to, or who are

intolerant of, methotrexate.

Press Release

29. Synribo omacetaxine

mepesuccinate

10/26/12 To treat adults with chronic myelogenous

leukemia (CML), a blood and bone marrow

disease.

Press Release

28. Fycompa perampanel 10/22/12 To treat partial onset seizures in patients with

epilepsy ages 12 years and older.

Press Release

27. Jetrea ocriplasmin 10/17/12 To treat an eye condition called symptomatic

vitreomacular adhesion (VMA).

Press Release

26. Stivarga regorafenib 9/27/12 To treat patients with colorectal cancer that

has progressed after treatment and spread toother parts of the body (metastatic).

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203858&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203858&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm333285.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm333285.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203441&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203441&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm333171.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm333171.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=200677&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=200677&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332351.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332351.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=125349&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332341.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203469&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332252.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332252.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203756&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm330143.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm330143.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203214&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm327152.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm327152.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203585&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm325895.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm325895.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202834&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm325038.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm325038.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=125422&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm324369.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm324369.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203085&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203085&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm324369.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=125422&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm325038.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202834&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm325895.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203585&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm327152.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203214&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm330143.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203756&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332252.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203469&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332341.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=125349&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332351.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=200677&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Press Release

25. Choline C 11

Injection

Choline C 11

Injection

9/12/12 A Positron Emission Tomography (PET)

imaging agent used to help detect recurrent

prostate cancer.

Press Release

24. Aubagio teriflunomide 9/12/12 For the treatment of adults with relapsingforms of multiple sclerosis (MS).

Press Release

23. Bosulif bosutinib 9/4/12 To treat chronic myelogenous leukemia

(CML), a blood and bone marrow disease that

usually affects older adults.

Press Release

22. Xtandi enzalutamide 8/31/12 To treat men with late-stage (metastatic)

castration-resistant prostate cancer that has

spread or recurred, even with medical or

surgical therapy to minimize testosterone.Press Release

21. Linzess linaclotide 8/30/12 To treat chronic idiopathic constipation and to

treat irritable bowel syndrome with

constipation (IBS-C) in adults.

Press Release

20. Neutroval tbo-filgrastim 8/29/12 To reduce the time certain patients receiving

cancer chemotherapy experience severe

neutropenia, a decrease in infection-fighting

white blood cells called neutrophils.

Press Release

19. Stribild elvitegravir,

cobicistat,

emtricitabine,

tenofovir

disoproxil

fumarate

8/27/12 A once-a-day combination pill to treat HIV-1 infectionin adults who have never been treated for HIV

infection.

Press Release

18. Zaltrap ziv-aflibercept 8/3/12 For use in combination with a FOLFIRI (folinic acid,fluorouracil and irinotecan) chemotherapy regimen to

treat adults with colorectal cancer.

Press Release17. Tudorza

Pressair

aclidinium

bromide

7/23/12 For the long-term maintenance treatment ofbronchospasm associated with chronic obstructive

pulmonary disease (COPD), including chronic

bronchitis and emphysema.

Press Release

16. Kyprolis carfilzomib 7/20/12 To treat patients with multiple myeloma who have

received at least two prior therapies, including

treatment with Velcade (bortezomib) and an

immunomodulatory.

Press Release

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm321271.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm321271.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203155&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203155&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm319201.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm319201.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202992&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202992&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm319277.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm319277.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203341&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm318160.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm318160.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203415&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317838.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317838.htmhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm336115.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317505.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317505.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=125294&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317392.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317392.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203100&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317004.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317004.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=125418&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=125418&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm314372.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm314372.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202450&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202450&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202450&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm313052.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm313052.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202714&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202714&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312920.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312920.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312920.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202714&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm313052.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202450&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202450&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm314372.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=125418&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317004.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203100&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317392.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=125294&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317505.htmhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm336115.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317838.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203415&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm318160.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203341&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm319277.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202992&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm319201.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203155&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203155&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm321271.htm

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15. Prepopik sodium picosulfate,magnesium oxide

and citric acid

7/16/12 To help cleanse the colon in adults preparing forcolonoscopy.

Press Release

14. Myrbetriq mirabegron 6/28/12 To treat adults with overactive bladder.Press Release

13. Belviq lorcaserinhydrochloride 6/27/12 For chronic weight management.Press Release

12. Perjeta pertuzumab 6/8/12 To treat patients with HER2-positive late-

stage (metastatic) breast cancer.

Press Release

11. Elelyso taliglucerase

alfa

5/1/12 For long-term enzyme replacement therapy to

treat a form of Gaucher disease, a rare genetic

disorder

Press Release

10. Stendra avanafil 4/27/12 To treat erectile dysfunction.

Press Release

9. Amyvid Florbetapir F 18 4/6/12 Used as a radioactive diagnostic agent forPositron Emission Tomography (PET)

imaging of the brain to estimate -amyloid

neuritic plaque density in adult patients with

cognitive impairment who are being evaluated

for Alzheimers Disease (AD) and other

causes of cognitive decline.

8. Omontys peginesatide 3/27/12 To treat anemia, a condition in which the body

does not have enough healthy red blood cells, in

adult dialysis patients who have chronic kidney

disease (CKD).Press Release

7. Surfaxin lucinactant 3/6/12 For the prevention of respiratory distress

syndrome (RDS), a breathing disorder that affects

premature infants.

Press Release

6. Zioptan tafluprost 2/10/12 For reducing elevated intraocular pressure in

patients with open-angle glaucoma or ocular

hypertension.Press Release

5. Kalydeco ivacaftor 1/31/12 For the treatment of a rare form of cystic

fibrosis (CF) in patients ages 6 years and

older who have the specific G551D mutation

in the Cystic Fibrosis Transmembrane

Regulator (CFTR) gene.

Press Release

4. Erivedge vismodegib 1/30/12 To treat adult patients with basal cell

carcinoma, the most common type of skin

cancer.Press Release

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202535&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202535&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312315.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312315.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202611&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202611&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310096.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310096.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=022529&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm309993.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm309993.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=125409&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm307549.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm307549.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=022458&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm302549.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm302549.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202276&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm302140.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm302140.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202008&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202799&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm297464.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm297464.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=021746&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm294984.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm294984.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202514&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm291966.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm291966.htmhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm336115.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm289633.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm289633.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203388&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm289545.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm289545.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm289545.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=203388&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm289633.htmhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm336115.htmhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm291966.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202514&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm294984.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=021746&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm297464.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202799&SearchType=BasicSearchhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202008&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm302140.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202276&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm302549.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=022458&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm307549.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=125409&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm309993.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=022529&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310096.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202611&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312315.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202535&SearchType=BasicSearch

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3. Inlyta axitinib 1/27/12 To treat patients with advanced kidney cancer

(renal cell carcinoma) who have not

responded to another drug for this type of

cancer.

Press Release

2. Picato ingenolmebutate

1/23/12 For the topical treatment of actinic keratosis.

1. Voraxaze glucarpidase 1/17/12 To treat patients with toxic levels of

methotrexate in their blood due to kidney

failure.

Press Release

2013

No. Drug Name Active Ingredient Date What its used for

21. Gazyva obinutuzumab 11/1/2013 For use in combination with

chlorambucil to treat patients with

previously untreated chronic

lymphocytic leukemia (CLL).

Press Release

20. Vizamyl flutemetamol F 18

injection

10/25/13 A radioactive diagnostic drug for use

with positron emission tomography

(PET) imaging of the brain in adults

being evaluated for Alzheimer's

disease (AD) and dementia.

Press Release19. Opsumit macitentan 10/18/13 To treat adults with pulmonary arterial

hypertension (PAH), a chronic,

progressive and debilitating disease

that can lead to death or the need for

lung transplantation.

Press Release

18. Adempas riociguat 10/8/13 To treat adults with two forms of

pulmonary hypertension.

Press Release

17. Duavee conjugated

estrogens/bazedoxifene

10/3/13 To treat moderate-to-severe hot flashes

(vasomotor symptoms) associated with

menopause and to prevent osteoporosis

after menopause.

Web Posting

16. Brintellix vortioxetine 9/30/13 To treat adults with major depressive

disorder.

Press Release

15. Tivicay dolutegravir 8/12/13 To treat HIV-1 infection.

Press Release

*

14. Gilotrif afatinib 7/12/13 For patients with late stage (metastatic)non-small cell lung cancer (NSCLC)

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whose tumors express specific types of

epidermal growth factor receptor

(EGFR) gene mutations, as detected by

an FDA-approved test.

Press Release

13. Mekinist trametinib 5/29/13 To treat patients whose tumors expressthe BRAF V600E or V600K gene

mutations.

Press Release

12. Tafinlar dabrafenib 5/29/13 To treat patients with melanoma whose

tumors express the BRAF V600E gene

mutation.

Press Release

11. Xofigo radium Ra 223

dichloride

5/15/13 To treat men with symptomatic late-

stage (metastatic) castration-resistant

prostate cancer that has spread tobones but not to other organs.

Press Release

10. Breo Ellipta fluticasone furoate and

vilanterol inhalation

powder

5/10/13 For the long-term, once-daily,

maintenance treatment of airflow

obstruction in patients with chronic

obstructive pulmonary disease

(COPD), including chronic bronchitis

and/or emphysema.

Press Release

9. Invokana canagliflozin 3/29/13 Used with diet and exercise, to

improve glycemic control in adultswith type 2 diabetes.

Press Release

8. Tecfidera dimethyl fumarate 3/27/13 To treat adults with relapsing forms of

multiple sclerosis (MS).

Press Release

7. Dotarem gadoterate meglumine 3/20/13 For use in magnetic resonance imaging

(MRI) of the brain, spine and

associated tissues of patients ages 2

years and older.

Press Release

6. Lymphoseek technetium Tc 99m

tilmanocept

3/13/13 A radioactive diagnostic imaging agent

that helps doctors locate lymph nodes

in patients with breast cancer or

melanoma who are undergoing surgery

to remove tumor-draining lymph

nodes.

Press Release

5. Osphena ospemifene 2/26/13 To treat women experiencing moderate

to severe dyspareunia (pain during

sexual intercourse), a symptom of

vulvar and vaginal atrophy due tomenopause.

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dex.cfm?fuseaction=Search.SearchAction&searchTerm=203971&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm354199.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=202806&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm354199.htmhttp://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=204114&SearchType=BasicSearchhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm360499.htm

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Press Release

4. Kadcyla ado-trastuzumab

emtansine

2/22/13 For patients with HER2-positive, late-

stage (metastatic) breast cancer.

Press Release

3. Pomalyst pomalidomide 2/8/13 To treat patients with multiple

myeloma whose disease progressedafter being treated with other cancer

drugs.

Press Release

2. Kynamro mipomersen sodium 1/29/13 To treat patients with a rare type of

high cholesterol called homozygous

familial hypercholesterolemia (HoFH).

Press Release

1. Nesina alogliptin 1/25/13 To improve blood sugar control in

adults with type 2 diabetes.

Press Release

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