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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 Name | Approval Date | Indication | Orphan Drug | Approved first in US | PDUFA date met | Approved on 1st cycle | Sponsor |
|---|---|---|---|---|---|---|---|
| Adcetris (brentuximab vedotin) | 8/19/11 | For treatment of Hodgkin's lymphoma and ALCL (systemic anaplastic large cell lymphoma). | X | X | X | X | Seattle Genetics Bothell, WA |
| Anascorp (Centruroides [Scorpion] Immune F(ab’)2 [Equine]) | 8/3/11 | For treatment of clinical signs of scorpion envenomation. | X | X | Rare Disease Therapeutics, Inc., Franklin,TN | ||
| Benlysta (belimumab) | 3/9/11 | To 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 | X | Human Genome Sciences, Inc., Rockville, MD co-marketed with GlaxoSmithKline, Philadelphia, PA | |
| Caprelsa (vandetanib) | 4/6/11 | To 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 | X | X | X | AstraZeneca Pharmaceuticals LP, Wilmington, DE |
| Corifact (Factor XIII Concentrate [Human]) | 2/17/11 | For routine prophylactic treatment of congenital Factor XIII deficiency. | X | X | X | CSL Bhering GmbH, King of Prussia, PA | |
| DaTscan (ioflupane i-123) | 1/14/11 | For brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian Syndrome. | X | GE Healthcare, Inc., Princeton, NJ | |||
| Dificid (fidaxomicin) | 5/27/11 | For treatment of Clostridium difficile-associated diarrhea (CDAD). | X | X | X | Optimer Pharmaceuticals Inc., San Diego, CA | |
| Firazyr (icatibant) | 8/25/11 | For 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 | ||
| Halaven (eribulin mesylate | 11/15/10 | For treatment of patients with metastatic (late-stage) breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease | X | X | X | Eisai, Inc., Woodcliff Lake, NJ | |
| Incivek (telaprevir) | 5/23/11 | For treatment of certain adults with chronic hepatitis C infection. | X | X | X | Vertex Pharmaceuticals, Cambridge, MA | |
| Pradaxa (dabigatran etexilate) | 10/19/10 | To reduce the risk of stroke and blood clots in patients with abnormal heart rhythms (non-valvular atrial fibrillation). | X | X | Boehringer Ingelheim Pharm, Inc, Ridgefield, CT | ||
| Victrelis (boceprevir) | 5/13/11 | To treat certain adults with chronic hepatitis C infection. | X | X | X | Merck, Whitehouse Station, NJ | |
| Xalkori (crizotinib) and companion genetic test | 8/26/11 | To 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. | X | X | X | X | Xalkori 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) | 3/25/11 | To treat patients with metastatic melanoma (late-stage skin cancer). | X | X | X | X | Bristol-Meyers Squibb, New York, NY |
| Zelboraf (vemuranfenib) with companion diagnostic | 8/17/11 | To 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. | X | X | X | X | Zelboraf 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) | 4/28/11 | To use In combination with prednisone (a steroid), to treat patients with metastatic (late-stage) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). | X | X | X | Centocor Ortho Biotech, Inc., Horsham, PA |
II. Standard Drugs
| Drug Name | Approval Date | Indication | Orphan Drug | Approved first in US | PDUFA date met | Approved on 1st cycle | Sponsor |
|---|---|---|---|---|---|---|---|
| Arcapta Neohaler (indacaterol inhalation powder) | 7/1/11 | For 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) | 3/16/11 | For 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. | X | X | Teva Women’s Health, Inc., Horsham, PA | ||
| Brilinta (ticagrelor) | 7/20/11 | To reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS). | X | AstraZeneca, Wilmington, DE | |||
| Daliresp (roflumilast) | 2/28/11 | To 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) | 2/25/11 | For treatment of high blood pressure (hypertension) in adults. | X | X | X | Takeda Pharmaceuticals North America Deerfield, IL | |
| Edurant (rilpivirine) | 5/20/11 | For treatment of HIV-1 infection in adults who have never taken HIV therapy. | X | X | X | Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc., Raritan, NJ | |
| Egrifta (tesamorelin acetate) | 11/10/10 | For reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. | X | X | Theratechnologies Inc., Montreal, Canada Marketed in US by EMD Serono, Inc., Rockland, MA | ||
| Gadavist (gadobutrol) | 3/14/11 | Contrast agent to help detect lesions in patients undergoing magnetic resonance imaging (MRI) of the central nervous system | X | X | Bayer Pharmaceuticals Wayne, NJ | ||
| Horizant (gabapentin enacarbil) | 4/6/11 | For once-daily treatment for moderate-to-severe restless legs syndrome (RLS). | X | X | GlaxoSmithKline, Research Triangle Park, NC and Xenoport, Santa Clara, CA | ||
| Latuda (lurasidone hydrochloride) | 10/28/10 | For treatment of schizophrenia in adults. | X | X | X | Sunovian Pharm, Inc Fort Lee, NJ | |
| LaViv (Azficel-T) | 6/21/11 | For improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. | X | X | Fibrocell Technologies, Inc., Exton, PA | ||
| Natroba (spinosad) | 1/18/11 | For treatment of head lice infestation in patients ages 4 years and older. | X | X | ParaPRO, LLC, Carmel, IN | ||
| Nulojix (belatacept) | 6/15/11 | To prevent organ rejection in adult patients who have had a kidney transplant, in combination with other immunosuppressants. | X | X | X | Bristol-Meyers Squibb, Princeton, NJ | |
| Potiga (ezogabine) | 6/10/11 | For 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) | 7/29/11 | For detection of delayed type hypersensitivity to C. immitis in individuals, 18-64 years of age, with a history of pulmonary coccidioidomycosis. | X | X | X | Allermed Laboratories, Inc., San Diego, CA | |
| Teflaro (ceftaroline fosamil) | 10/29/10 | For treatment of acute bacterial skin and skin structure infections and community acquired bacterial pneumonia. | X | X | X | Cerexa, Inc., Oakland, CA | |
| Tradjenta (linagliptin) | 5/2/11 | For use as an adjunct to diet and exercise to improve glycemic (blood sugar) control in adults with type 2 diabetes. | X | X | X | Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT and Eli Lilly Co., Indianapolis, IN | |
| Viibryd (vilazodone hydrochloride) | 1/21/11 | For treatment of major depressive disorder in adults. | X | X | X | PGxHealth, New Haven, CT | |
| Xarelto (rivaroxaban) | 7/1/11 | To 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
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