New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

February 2009

February 2

Acorda Therapeutics Submits NDA for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis 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 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 Roxro Announces FDA Accepts for Review NDA for ROX-888 for the Management of Acute Moderate to Severe Pain 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 FDA Accepts Amgen's Submission and Files Biologics License Application for Denosumab Zogenix Reports FDA Provides New PDUFA Date for Sumavel DosePro Acusphere Announces Change In Imagify Regulatory Strategy and Deferral of Near-Term Contractual Cash Payments

February 19

FDA Accepts Nuvo's Resubmission For Pennsaid 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) Theravance Receives Complete Response Letter on the Telavancin New Drug Application for the Treatment of cSSSI AstraZeneca Receives FDA Complete Response Letter On Seroquel XR For Generalised Anxiety Disorder Salix Announces FDA Complete Response Letter for Metozolv ODT Advanced Life Sciences Receives Notice of Planned Cethromycin Review by FDA Advisory Committee

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