New Drug Applications Archive - September 2005
Get news by email or subscribe to our news feeds.
September 1, 2005
- Approvable Letter Received from the FDA for Dacogen (Decitabine) Injection for the Treatment of MDS.
September 6, 2005
- Bristol-Myers Squibb Statement on FDA Advisory Committee Vote on Orencia (Abatacept), an Investigational Selective Modulator of T-Cell Co-Stimulation for Rheumatoid Arthritis
- Cephalon Files New Drug Application for OraVescent Fentanyl for the Management of Breakthrough Pain in Cancer Patients
September 8, 2005
September 9, 2005
September 13, 2005
- FDA Advisory Committee Does Not Recommend Approval of Xinlay (atrasentan)
- Pfizer Statement on Lasofoxifene
- Eisai Submits New Drug Application to the FDA for Anti-epileptic Drug Rufinamide
- FDA and Celgene Revlimid Briefing Documents for Advisory Committee Meeting Available Online
September 14, 2005
- FDA Oncologic Drugs Advisory Committee Recommends Revlimid for Full Approval
- FDA Advisory Committee Recommends Accelerated Approval of GlaxoSmithKline's Arranon (nelarabine) Injection
- Sandoz Files Lawsuit Seeking FDA Ruling on Omnitrope
- Bayer and Onyx Announce FDA Acceptance of New Drug Application for Sorafenib for Individuals with Advanced Renal Cell Carcinoma
- Salvat Announces the FDA Acceptance of NDA for its Cetraxal Otic Solution
- Dendreon Announces Plans to Submit BLA
September 20, 2005
- FDA Extends PDUFA Date for Vivitrex to December 30, 2005
- Pfizer Receives FDA Non-Approvable Letter on Parecoxib
September 21, 2005
September 22, 2005
September 23, 2005
September 26, 2005
- Ceragenix Submits 510(k) Application to FDA for Epiceram, a Skin Barrier Cream for Treatment of Eczema and Other Skin Disorders
- FDA Accepts for Filing a License Application for New Pediatric Combination Vaccine, Pentacel
