New Drug Applications Archive

New Drug Applications: March 2009

March 2	US Food and Drug Administration Issues Complete Response Letter Regarding the Tracleer Supplemental New Drug Application
March 2	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.
March 2	Pharmaxis Announces New Drug Application Submission for Aridol
March 3	Genzyme Receives Complete Response Letter from FDA on Lumizyme Application
March 3	Acurox Tablets New Drug Application Accepted for Filing With a Priority Review Classification
March 5	FDA Provides PDUFA Target Agency Action Date For GTx's Toremifene 80 mg NDA
March 6	Takeda Receives New Information on Alogliptin (SYR-322) NDA
March 9	FDA Appeal Decision Indicates that Genasense Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Trial
March 9	Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. Food and Drug Administration
March 12	FDA Accepts Complete Response Submission to New Drug Application for Nebido
March 16	XenoPort to Receive $23 Million in Milestone Payments Associated With FDA Acceptance of Solzira NDA
March 16	United Therapeutics Announces Probable Delay in Approval Timeline for Inhaled Treprostinil (Tyvaso)
March 16	Zenvia Phase III PBA Trial Completes Patient Enrollment
March 16	Sirion Therapeutics Supplemental New Drug Application for Durezol to Treat Uveitis is Accepted for Review by the FDA
March 16	MannKind Submits NDA for Afresa for Treatment of Diabetes
March 18	Questcor Submits Supplemental New Drug Application to FDA for H.P. Acthar Gel for Treatment of Infantile Spasms
March 19	OSI Pharmaceuticals Submits sNDA for Tarceva as a First-Line Maintenance Therapy in Advanced NSCLC
March 19	FDA Advisory Committee Recommends Approval of Multaq (dronedarone)
March 20	FDA Advisory Committee Finds Favorable Risk-Benefit Profile for Oral Anticoagulant Rivaroxaban for Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism After Hip or Knee Replacement Surgery
March 25	Allos Therapeutics Submits New Drug Application for Pralatrexate for Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
March 26	Spectrum Pharmaceuticals Announces That FDA Has Accepted Fusilev sNDA for Colorectal Cancer Indication
March 27	Dyax Receives Complete Response Letter from FDA for DX-88 in Acute Attacks of Hereditary Angioedema
March 30	Cervarix U.S. Regulatory Update
March 31	Sepracor Announces Submission of Stedesa New Drug Application to FDA for Adjunctive Treatment of Epilepsy
March 31	Acorda Therapeutics Receives Refuse to File Letter from FDA on Fampridine-SR NDA
March 31	Wyeth Submits Marketing Application to FDA for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in Infants and Toddlers
March 31	FDA Advisory Committee Unanimously Recommends Accelerated Approval of Avastin for Previously Treated Brain Cancer (Glioblastoma)

New Drug Applications Archive

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