New Drug Applications Archive - December 2005
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December 1, 2005
December 2, 2005
- Inspire Announces Receipt of FDA Approvable Letter for Diquafosol
- Noven Announces Results of Daytrana Advisory Committee Meeting
December 5, 2005
December 7, 2005
December 9, 2005
- FDA Extends Review Period of New Drug Application for Oral Contraceptive Yaz to First Quarter 2006
- Barrier Therapeutics Announces FDA Acceptance of its New Drug Application for Sebazole Topical Gel
December 13, 2005
- Sepracor Announces Submission of Arformoterol NDA to FDA for Chronic Obstructive Pulmonary Disease
- Noven to Commence Manufacture of Daytrana Methylphenidate Transdermal System
December 14, 2005
December 15, 2005
- Dacogen (Decitabine) Injection Complete Response Accepted for Review By U.S. FDA
- 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
- GPC Biotech Begins Rolling NDA Submission for Lead Drug Candidate Satraplatin
December 22, 2005
- Endo Files Responses to FDA's Approvable Letters on NDAs for Oxymorphone ER and IR Tablets
- Shire Announces Filing of Mesavance (mesalamine) for Treatment of Ulcerative Colitis
- Wyeth Submits New Drug Application for Desvenlafaxine Extended Release (DVS-233) for Depression
December 23, 2005
December 26, 2005
December 27, 2005
December 28, 2005
- Bristol-Myers Squibb Submits New Drug Application for Dasatinib
- FDA Issues Approvable Letter for Vivitrol (formerly Vivitrex), for the Treatment of Alcohol Dependence
December 29, 2005
- Adolor Corporation Submits Investigational New Drug Application for Novel Delta Opioid Agonist Compound for the Management of Pain
- Genta Files New Drug Application for FDA Approval of Genasense Plus Chemotherapy for Patients with Advanced or Refractory Chronic Lymphocytic Leukemia
