New Drug Applications Archive - February 2009
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February 2, 2009
- 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, 2009
February 5, 2009
- 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, 2009
- 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
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and Invega
February 11, 2009
February 12, 2009
February 17, 2009
February 18, 2009
- 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, 2009
- 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, 2009
February 27, 2009
- 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
