August Full Approvals
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Full approvals of NDAs and BLAs.
|
Product and Sponsor |
Indication |
Date Approved (Application No.) |
|
New Drugs |
||
|
Auvi-Q Epinephrine Intelliject Inc. 5S |
Full approval via the 505(b)(2) NDA pathway of the non-selective alpha- and beta-adrenergic receptor agonist Auto-Injector for emergency treatment of allergic reactions including anaphylaxis; received tentative approval July 29, 2011 |
8/10/2012 (201-739) |
|
Linzess Linaclotide Forest Laboratories Inc./Ironwood Pharmaceuticals Inc. 1S |
Guanylate cyclase-C capsules for treatment of irritable bowel syndrome with constipation and for treatment of chronic idiopathic constipation |
8/30/2012 (202-811) |
|
Marqibo Vincristine Talon Therapeutics Inc. 5S |
Vinca alkaloid given accelerated approval under the 505(b)(2) NDA pathway to treat adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies |
8/9/2012 (202-497) |
|
Rivalto Sildenafil Pfizer Inc. 3P |
Phosphodiesterase-5 inhibitor in oral suspension for the treatment of pulmonary arterial hypertension in adults |
8/30/2012 (203-109) |
|
Stribild Elvitegravir/cobicistat/emtricitabine/tenofovir Gilead Sciences Inc. 1S |
Fixed dose combination of an integrase inhibitor, a pharmacokinetic enhancer and two nucleos(t)ide reverse transcriptase inhibitors for treatment of HIV-1 infection in treatment-naïve adults |
8/27/2012 (203-100) |
|
Xtandi Enzalutamide Medivation Inc. 1P |
Androgen receptor inhibitor for treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel |
8/31/2012 (203-415) |
|
New Biologics |
||
|
Neutroval Tbo-filgrastim Sicor Biotech UAB/Teva Pharmaceuticals U.S.A. |
Leucocyte growth factor for reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia |
8/29/2012 (125294) |
|
Zaltrap Ziv-aflibercept Regeneron Pharmaceuticals Inc./Sanofi-Aventis U.S. LLC |
Angiogenesis inhibitor for use in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI) for patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen |
8/3/2012 (125418) |
|
P: Priority Review (drug represents therapeutic gain over existing therapies) S: Standard Review V: Orphan Drug 1: New molecular entity 2: New salt 3: New formulation 4: New combination 5: Already marketed in U.S. by another firm 6: Already marketed by same firm, usually a new indication 7: First NDA for already marketed drug |
||