New Drug Applications Archive

New Drug Applications: February 2009

February 2	Acorda Therapeutics Submits NDA for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis
February 2	EpiCept Receives Permission to File Ceplene NDA
February 4	Prasugrel Receives Unanimous Approval Recommendation from FDA Advisory Committee
February 5	FDA Advisory Committee Favors Approval of DX-88 for Acute Attacks of Hereditary Angioedema
February 5	Tibotec Submits Application to U.S. Food and Drug Administration Seeking Traditional Approval for Intelence (etravirine)
February 6	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and Invega
February 6	Roxro Announces FDA Accepts for Review NDA for ROX-888 for the Management of Acute Moderate to Severe Pain
February 6	UCB's meeting with U.S. FDA defines path forward for Cimzia in rheumatoid arthritis
February 11	FDA Issues Complete Response Letter for Risperdal Consta for the Adjunctive Maintenance Treatment of Bipolar Disorder
February 12	Savient Provides Update on Pegloticase BLA
February 17	Vion Pharmaceuticals Submits New Drug Application for Onrigin
February 18	GTx Announces Toremifene 80 mg NDA Accepted for Review by FDA
February 18	Zogenix Reports FDA Provides New PDUFA Date for Sumavel DosePro
February 18	FDA Accepts Amgen's Submission and Files Biologics License Application for Denosumab
February 18	Acusphere Announces Change In Imagify Regulatory Strategy and Deferral of Near-Term Contractual Cash Payments
February 19	FDA Accepts Nuvo's Resubmission For Pennsaid
February 19	Gilead Receives Response From U.S. FDA on Company's Request for Formal Dispute Resolution for Aztreonam for Inhalation Solution
February 20	Schering-Plough Submits Response to FDA for Saphris (asenapine) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder
February 27	Somaxon Receives Complete Response Letter from the FDA for Silenor (doxepin)
February 27	Theravance Receives Complete Response Letter on the Telavancin New Drug Application for the Treatment of cSSSI
February 27	AstraZeneca Receives FDA Complete Response Letter On Seroquel XR For Generalised Anxiety Disorder
February 27	Salix Announces FDA Complete Response Letter for Metozolv ODT
February 27	Advanced Life Sciences Receives Notice of Planned Cethromycin Review by FDA Advisory Committee

New Drug Applications Archive

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