FDA sets Feb. 9 for ODAC meeting to review CTI’s resubmitted pixantrone NDA
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Posts tagged: nda
Comments (0)Eisai resubmits NDA for perampanel to treat epilepsy-associated seizures
Eisai Inc. announced today that it resubmitted the New Drug Application (NDA) for the investigational AMPA-type glutamate receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the U.S. Food and Drug Administration (FDA) on December 22, 2011.
FDA EMDAC schedules to review VIVUS’ Qnexa NDA for treatment of obesity
VIVUS, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review the Company's New Drug Application (NDA) for Qnexa for the treatment of obesity on February 22, 2012.
FDA accepts Pfizer’s tofacitinib NDA for review
Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tofacitinib (development code CP-690,550), an investigational novel, oral JAK inhibitor being studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
FDA accepts Vertex KALYDECO NDA for six-month Priority Review
Vertex Pharmaceuticals Incorporated announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for KALYDECOTM (ivacaftor) and granted the company's request for six-month Priority Review.
Salix submits Crofelemer NDA to FDA for treatment of HIV-associated diarrhea
Salix Pharmaceuticals, Ltd. today announced that the Company has submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for Crofelemer for the proposed treatment of HIV-associated diarrhea.
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Onyx receives FDA Standard Review designation for carfilzomib NDA to treat RRMM
Onyx Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Standard Review designation to the New Drug Application (NDA) for carfilzomib for the potential treatment of patients with relapsed and refractory multiple myeloma.
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PDUFA goal date of NDA for Protalix’s taliglucerase alfa extended
Protalix BioTherapeutics, Inc., announced today that it received notification from the U.S. Food and Drug Administration (FDA) that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date of the New Drug Application (NDA) for taliglucerase alfa to May 1, 2012, a three-month extension from the previous ...
Mylan’s NDA for Atazanavir Sulfate and Ritonavir Tablets receives tentative FDA approval through PEPFAR
Mylan Inc. today announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration through the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Atazanavir Sulfate and Ritonavir Tablets, 300 mg/100 mg.
Arbor files first NDA with U.S. FDA
Arbor Pharmaceuticals announced today that it has filed its first New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The recently filed product has been granted an Orphan designation by the FDA which provides seven years of market exclusivity.
FDA assigns priority-review designation for ELIQUIS NDA for stroke prevention in atrial fibrillation
Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for ELIQUIS® (apixaban), an investigational compound for the prevention of stroke and systemic embolism in patients with atrial fibrillation.
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Takeda submits alogliptin plus metformin NDA to FDA for treatment of type 2 diabetes
Takeda Pharmaceutical Company Limited (Takeda) announced today that its wholly-owned subsidiary Takeda Global Research & Development Center, Inc., U.S., submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for the fixed-dose combination therapy alogliptin/metformin, which combines alogliptin with metformin in a single tablet.