New Drug Applications Archive - June 2005
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June 1, 2005
- Inspire Submits Amendment to New Drug Application for Diquafosol for the Treatment of Dry Eye
- Allergan Receives Written Response from FDA on Oral Tazarotene
- Mylan Laboratories Receives Approvable Letter For Its Next Generation Beta-Blocker Nebivolol
June 2, 2005
- NovaDel Pharma Receives Approvable Letter from the FDA for NitroMist - nitroglycerin lingual aerosol
- Vicuron Pharmaceuticals Receives Issued Patent for Dalbavancin Dosing by U.S. Patent and Trademark Office
June 7, 2005
June 10, 2005
- FDA Extends PDUFA Date for SomatoKine to October 3, 2005
- SALVAT Files NDA for its Cetraxal Otic - Ciprofloxacin Otic- 0.2% Solution, for the Treatment of External Otitis
June 13, 2005
- U.S. FDA Agrees to Rolling New Drug Application for Virulizin
- Connetics Receives FDA Non-Approvable Letter for Velac
June 14, 2005
June 15, 2005
June 16, 2005
- FDA Advisory Committee Recommends Approval for NitroMed's BiDil to Treat Black Patients With Heart Failure
- Somerset Files Response to Emsam Action Letter
June 17, 2005
June 21, 2005
- Organon Receives Approvable From FDA for Contraceptive Implant
- FDA Grants Priority Review for Revlimid NDA for Treatment of Low- and Intermediate- Risk MDS With Deletion 5q Chromosomal Abnormality
June 22, 2005
June 23, 2005
June 28, 2005
June 29, 2005
- Penwest Receives Non-Approvable Letter from FDA for PW2101
- FDA Sets August 4, 2005 for Advisory Committee Meeting to Consider Tardive Dyskinesia Risk with MT 100
- Merck Announces that FDA Has Accepted For Review Biologics License Applications for Rotateq and Zostavax
- Merck Announces that FDA Has Accepted For Review Biologics License Applications for Rotateq and Zostavax
June 30, 2005
- FDA Agrees to File and Review NDA for Fibrillex
- Halozyme Therapeutics Announces Submission of Investigational New Drug Application
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Receives Not Approvable Letter From FDA for Tipifarnib Based on Phase II Data
- Genta Initiates New Drug Application for Genasense in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
- Takeda Submits New Drug Application for Combination Type 2 Diabetes Medication Containing Pioglitazone HCl and Glimepiride
- Cellegy Reports Status of Response Date for FDA Review
- Avanir Submits NDA for Neurodex
