New Drug Applications: September 2005

September 1	Approvable Letter Received from the FDA for Dacogen (Decitabine) Injection for the Treatment of MDS.
September 1	Eisai Submits Application to FDA for Aricept for Treatment of Severe Alzheimer's Disease
September 6	Cephalon Files New Drug Application for OraVescent Fentanyl for the Management of Breakthrough Pain in Cancer Patients
September 6	Bristol-Myers Squibb Statement on FDA Advisory Committee Vote on Orencia (Abatacept), an Investigational Selective Modulator of T-Cell Co-Stimulation for Rheumatoid Arthritis
September 8	FDA Advisory Committee Recommends Approval of Exubera for Use in Adults With Type 1 and 2 Diabetes
September 9	Bristol-Myers Squibb and Merck Joint Statement on FDA Advisory Committee Vote on Pargluva (Muraglitazar), an Investigational Oral Treatment for Type 2 Diabetes
September 13	Eisai Submits New Drug Application to the FDA for Anti-epileptic Drug Rufinamide
September 13	FDA Advisory Committee Does Not Recommend Approval of Xinlay (atrasentan)
September 13	Pfizer Statement on Lasofoxifene
September 13	FDA and Celgene Revlimid Briefing Documents for Advisory Committee Meeting Available Online
September 14	Dendreon Announces Plans to Submit BLA
September 14	Salvat Announces the FDA Acceptance of NDA for its Cetraxal Otic Solution
September 14	Sandoz Files Lawsuit Seeking FDA Ruling on Omnitrope
September 14	Bayer and Onyx Announce FDA Acceptance of New Drug Application for Sorafenib for Individuals with Advanced Renal Cell Carcinoma
September 14	FDA Advisory Committee Recommends Accelerated Approval of GlaxoSmithKline's Arranon (nelarabine) Injection
September 14	FDA Oncologic Drugs Advisory Committee Recommends Revlimid for Full Approval
September 20	Pfizer Receives FDA Non-Approvable Letter on Parecoxib
September 20	FDA Extends PDUFA Date for Vivitrex to December 30, 2005
September 21	BioSante Encouraged by FDA Panel on Exubera, Superior Results of Own Inhaled Insulin Study
September 22	Further Update on Avanir's Neurodex New Drug Application
September 23	AstraZeneca Submits New Drug Application (NDA) to FDA for Symbicort Maintenance Treatment of Asthma
September 26	FDA Accepts for Filing a License Application for New Pediatric Combination Vaccine, Pentacel
September 26	Ceragenix Submits 510(k) Application to FDA for Epiceram, a Skin Barrier Cream for Treatment of Eczema and Other Skin Disorders
September 27	Insmed Receives Approvable Letter for iPlex
September 29	NeoPharm Announces LEP-ETU Project Update
September 29	FDA Advisory Committee Votes Unanimously to Recommend Approval of Exjade for Once-Daily Oral Treatment of Chronic Iron Overload Due to Blood Transfusions
September 29	Arranon Cancer Drug Receives Advisory Committee Support

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New Drug Applications: September 2005

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