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Appendix: Chronological List of 35 Novel Drug Approvals in FY 2011

Previous Section: Ongoing Support of Innovation

I. Priority Drugs

Drug NameApproval DateIndicationOrphan DrugApproved first
in US
PDUFA date
Approved on 1st cycleSponsor
Adcetris (brentuximab vedotin)8/19/11For treatment of Hodgkin's lymphoma and ALCL (systemic anaplastic large cell lymphoma).XXXXSeattle Genetics
Bothell, WA
Anascorp (Centruroides [Scorpion] Immune F(ab’)2 [Equine])8/3/11For treatment of clinical signs of scorpion envenomation.X  X  Rare Disease Therapeutics, Inc., Franklin,TN
Benlysta (belimumab)3/9/11To treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs. X X XHuman Genome Sciences, Inc., Rockville, MD
co-marketed with GlaxoSmithKline,
Philadelphia, PA
4/6/11To treat adult patients with metastatic (late-stage ) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms.X XXXAstraZeneca Pharmaceuticals LP, Wilmington, DE
(Factor XIII Concentrate [Human])
  2/17/11For routine prophylactic treatment of congenital Factor XIII deficiency.X  X XCSL Bhering GmbH,
King of Prussia, PA
  1/14/11For brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian Syndrome.  X  GE Healthcare, Inc.,
Princeton, NJ
Dificid (fidaxomicin)5/27/11For treatment of Clostridium difficile-associated diarrhea (CDAD). XXXOptimer Pharmaceuticals Inc.,
San Diego, CA
Firazyr (icatibant)8/25/11For treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older. X X Shire Human Genetic Therapies Inc.,
Cambridge, MA
(eribulin mesylate
11/15/10For treatment of patients with metastatic (late-stage) breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease XXXEisai, Inc.,
Woodcliff Lake, NJ
Incivek (telaprevir)5/23/11For treatment of certain adults with chronic hepatitis C infection. XXXVertex Pharmaceuticals, Cambridge, MA
(dabigatran etexilate)
10/19/10To reduce the risk of stroke and blood clots in patients with abnormal heart rhythms (non-valvular atrial fibrillation).  X XBoehringer Ingelheim Pharm,
Ridgefield, CT
Victrelis (boceprevir)5/13/11To treat certain adults with chronic hepatitis C infection. XXXMerck,
Whitehouse Station, NJ
Xalkori (crizotinib) and companion genetic test8/26/11To treat certain patients with late stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene.XXXXXalkori is marketed by Pfizer, New York, NY, and the Vysis ALK Break Apart FISH Probe Kit is marketed by Abbott Molecular Inc. of Des Plaines, IL.
Yervoy (ipilimumab)3/25/11To treat patients with metastatic melanoma (late-stage skin cancer).XXXXBristol-Meyers Squibb,
New York, NY
Zelboraf (vemuranfenib) with companion diagnostic8/17/11To treat patients with metastatic (late-stage) or unresected (cannot be removed by surgery) melanoma (skin cancer) in patients whose tumors express a gene mutation called BRAF V600E.XXXXZelboraf is marketed by Genentech, a member of the Roche Group, South San Francisco, CA. 
The cobas 4800 BRAF V600 Mutation Test is manufactured by Roche Molecular Systems, Pleasanton, CA
Zytiga (albiraterone acetate)4/28/11To use In combination with prednisone (a steroid), to treat patients with metastatic (late-stage) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). XXXCentocor Ortho Biotech, Inc., Horsham, PA


II. Standard Drugs

Drug NameApproval DateIndicationOrphan DrugApproved first
in US
PDUFA date metApproved on 1st cycleSponsor
Arcapta Neohaler (indacaterol inhalation powder)7/1/11For long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.  X Novartis Pharmaceuticals Corp., East Hanover, NJ
Ardovax (Adenovirus Type 4 and Type 7 Vaccine, Live, Oral)3/16/11For active immunization for the prevention of febrile acute respiratory disease caused by Adenovirus Type 4 and Type 7. Adenovirus Type 4 and Type 7 Vaccine, Live, Oral is approved for use in military populations 17 through 50 years of age. XX Teva Women’s Health, Inc., Horsham, PA
Brilinta (ticagrelor)7/20/11To reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS).  X AstraZeneca, Wilmington, DE
Daliresp (roflumilast)2/28/11To decrease the frequency of flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD).  X  Forest Pharmaceuticals
St. Louis, MO
Edarbi (azilsartan medoxomil)2/25/11For treatment of high blood pressure (hypertension) in adults. XXXTakeda Pharmaceuticals North America
Deerfield, IL
Edurant (rilpivirine)5/20/11For treatment of HIV-1 infection in adults who have never taken HIV therapy. XXXTibotec Therapeutics, a division of Centocor Ortho Biotech Inc., Raritan, NJ
(tesamorelin acetate)
11/10/10For reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. X  XTheratechnologies Inc.,
Montreal, Canada
Marketed in US by EMD Serono, Inc., Rockland, MA
  3/14/11Contrast agent to help detect lesions in patients undergoing magnetic resonance imaging (MRI) of the central nervous system  X XBayer Pharmaceuticals
Wayne, NJ
Horizant (gabapentin enacarbil)4/6/11For once-daily treatment for moderate-to-severe restless legs syndrome (RLS). X X  GlaxoSmithKline,
Research Triangle Park, NC and Xenoport,
Santa Clara, CA
(lurasidone hydrochloride)
10/28/10For treatment of schizophrenia in adults. XXXSunovian Pharm, Inc
Fort Lee, NJ
LaViv (Azficel-T)6/21/11For improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. XX Fibrocell Technologies, Inc.,
Exton, PA
Natroba (spinosad)1/18/11For treatment of head lice infestation in patients ages 4 years and older. XX ParaPRO, LLC,
Carmel, IN
Nulojix (belatacept) 6/15/11To prevent organ rejection in adult patients who have had a kidney transplant, in combination with other immunosuppressants.XXX Bristol-Meyers Squibb,
Princeton, NJ
Potiga (ezogabine)6/10/11For use as an add-on medication to treat seizures associated with epilepsy in adults.  X  Developed by Valeant Pharmaceuticals North America, Durham, NC
Marketed by GlaxoSmithKline,
Research Triangle Park, NC.
Spherusol (Coccidioides immitis Spherule-Derived Skin Test Antigen)7/29/11For detection of delayed type hypersensitivity to C. immitis in individuals, 18-64 years of age, with a history of pulmonary coccidioidomycosis.XXX Allermed Laboratories, Inc.,
San Diego, CA
Teflaro (ceftaroline fosamil)10/29/10For treatment of acute bacterial skin and skin structure infections and community acquired bacterial pneumonia. XXXCerexa, Inc.,
Oakland, CA
Tradjenta (linagliptin)5/2/11For use as an adjunct to diet and exercise to improve glycemic (blood sugar) control in adults with type 2 diabetes. XXXBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT and Eli Lilly Co.,
Indianapolis, IN
Viibryd (vilazodone hydrochloride)1/21/11For treatment of major depressive disorder in adults. XXXPGxHealth,
New Haven, CT
Xarelto (rivaroxaban)7/1/11To reduce the risk of blood clots, deep vein thrombosis(DVT), and pulmonary embolism (PE) following knee or hip replacement surgery.  X  Janssen Pharmaceuticals, Inc., a member of the Janssen Pharmaceutical Companies of Johnson & Johnson,
Raritan, NJ.

Table of Contents: Innovative Drug Approvals