New Drug Applications Archive - March 2009
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March 2, 2009
- US Food and Drug Administration Issues Complete Response Letter Regarding the Tracleer Supplemental New Drug Application
- ImClone Systems and Bristol-Myers Squibb Update Status of First-Line Squamous Cell Carcinoma of the Head and Neck Supplemental Biologics Application for Erbitux in U.S.
- Pharmaxis Announces New Drug Application Submission for Aridol
March 3, 2009
- Genzyme Receives Complete Response Letter from FDA on Lumizyme Application
- Acurox Tablets New Drug Application Accepted for Filing With a Priority Review Classification
March 5, 2009
March 6, 2009
March 9, 2009
- FDA Appeal Decision Indicates that Genasense Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Trial
- Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. Food and Drug Administration
March 12, 2009
March 16, 2009
- XenoPort to Receive $23 Million in Milestone Payments Associated With FDA Acceptance of Solzira NDA
- United Therapeutics Announces Probable Delay in Approval Timeline for Inhaled Treprostinil (Tyvaso)
- Sirion Therapeutics Supplemental New Drug Application for Durezol to Treat Uveitis is Accepted for Review by the FDA
- Zenvia Phase III PBA Trial Completes Patient Enrollment
- MannKind Submits NDA for Afresa for Treatment of Diabetes
March 18, 2009
March 19, 2009
- OSI Pharmaceuticals Submits sNDA for Tarceva as a First-Line Maintenance Therapy in Advanced NSCLC
- FDA Advisory Committee Recommends Approval of Multaq (dronedarone)
March 20, 2009
March 25, 2009
March 26, 2009
March 27, 2009
March 30, 2009
March 31, 2009
- Sepracor Announces Submission of Stedesa New Drug Application to FDA for Adjunctive Treatment of Epilepsy
- Acorda Therapeutics Receives Refuse to File Letter from FDA on Fampridine-SR NDA
- Wyeth Submits Marketing Application to FDA for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in Infants and Toddlers
- FDA Advisory Committee Unanimously Recommends Accelerated Approval of Avastin for Previously Treated Brain Cancer (Glioblastoma)
