New Drug Applications: December 2005

December 1	MediGene Announces FDA Acceptance of New Drug Application for Polyphenon E Ointment for the Treatment of Genital Warts
December 2	Inspire Announces Receipt of FDA Approvable Letter for Diquafosol
December 2	Noven Announces Results of Daytrana Advisory Committee Meeting
December 5	Merck Submits Biologics License Application to FDA for Gardasil, the Company's Investigational Vaccine for Cervical Cancer
December 7	Shire Announces New River Pharmaceuticals Filing of NRP104
December 9	Barrier Therapeutics Announces FDA Acceptance of its New Drug Application for Sebazole Topical Gel
December 9	FDA Extends Review Period of New Drug Application for Oral Contraceptive Yaz to First Quarter 2006
December 13	Noven to Commence Manufacture of Daytrana Methylphenidate Transdermal System
December 13	Sepracor Announces Submission of Arformoterol NDA to FDA for Chronic Obstructive Pulmonary Disease
December 14	FDA Vaccines Advisory Committee Unanimously Agrees that Clinical Data from 70,000-Infant Phase III Trials Support the Efficacy and Safety of Rotateq, Merck's Investigational Vaccine for Rotavirus Gastroenteritis
December 15	GPC Biotech Begins Rolling NDA Submission for Lead Drug Candidate Satraplatin
December 15	FDA Advisory Committee Agrees that Clinical Data Support the Efficacy and Safety of Zostavax, Merck's Investigational Vaccine for Shingles, in Adults Aged 60 and Older
December 15	Dacogen (Decitabine) Injection Complete Response Accepted for Review By U.S. FDA
December 22	Wyeth Submits New Drug Application for Desvenlafaxine Extended Release (DVS-233) for Depression
December 22	Shire Announces Filing of Mesavance (mesalamine) for Treatment of Ulcerative Colitis
December 22	Endo Files Responses to FDA's Approvable Letters on NDAs for Oxymorphone ER and IR Tablets
December 23	FDA Issues Approvable Letter for Daytrana Methylphenidate Transdermal System
December 26	NDA for Immunosuppressant FK506 Modified Release Formulation Submitted in the US
December 27	New Drug Application for Investigational HIV Protease Inhibitor TMC114 Submitted to U.S. Food & Drug Administration
December 28	FDA Issues Approvable Letter for Vivitrol (formerly Vivitrex), for the Treatment of Alcohol Dependence
December 28	Bristol-Myers Squibb Submits New Drug Application for Dasatinib
December 29	Genta Files New Drug Application for FDA Approval of Genasense Plus Chemotherapy for Patients with Advanced or Refractory Chronic Lymphocytic Leukemia
December 29	Adolor Corporation Submits Investigational New Drug Application for Novel Delta Opioid Agonist Compound for the Management of Pain
December 30	Genentech Submits Biologics License Application for FDA Review of Lucentis in Wet Age-Related Macular Degeneration

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New Drug Applications: December 2005

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