New Drug Applications: June 2005

June 1	Inspire Submits Amendment to New Drug Application for Diquafosol for the Treatment of Dry Eye
June 1	Allergan Receives Written Response from FDA on Oral Tazarotene
June 1	Mylan Laboratories Receives Approvable Letter For Its Next Generation Beta-Blocker Nebivolol
June 2	Vicuron Pharmaceuticals Receives Issued Patent for Dalbavancin Dosing by U.S. Patent and Trademark Office
June 2	NovaDel Pharma Receives Approvable Letter from the FDA for NitroMist - nitroglycerin lingual aerosol
June 7	Revlimid (lenalidomide) New Drug Application Accepted for Review by FDA
June 10	SALVAT Files NDA for its Cetraxal Otic - Ciprofloxacin Otic- 0.2% Solution, for the Treatment of External Otitis
June 10	FDA Extends PDUFA Date for SomatoKine to October 3, 2005
June 13	U.S. FDA Agrees to Rolling New Drug Application for Virulizin
June 13	Connetics Receives FDA Non-Approvable Letter for Velac
June 14	Neurocrine Announces Acceptance of New Drug Application for Indiplon Capsules
June 15	Organizations Unite to Support BiDil's Approval for Heart Failure, Rebuff Designation as 'Race-Only' Drug
June 16	Somerset Files Response to Emsam Action Letter
June 16	FDA Advisory Committee Recommends Approval for NitroMed's BiDil to Treat Black Patients With Heart Failure
June 17	Merck Provides Status Update on Ongoing Arcoxia Trials
June 21	Organon Receives Approvable From FDA for Contraceptive Implant
June 21	FDA Grants Priority Review for Revlimid NDA for Treatment of Low- and Intermediate- Risk MDS With Deletion 5q Chromosomal Abnormality
June 22	FDA Grants Priority Review for Exjade for the Treatment of Chronic Iron Overload Due to Blood Transfusions
June 23	Rimonabant Accepted for Filing By the FDA
June 28	Santarus Announces FDA Acceptance of New Drug Application For Zegerid Capsules; FDA Action Expected in Early 2006 on NDA for First Immediate-Release Proton Pump Inhibitor in Capsule Formulation
June 29	FDA Sets August 4, 2005 for Advisory Committee Meeting to Consider Tardive Dyskinesia Risk with MT 100
June 29	Penwest Receives Non-Approvable Letter from FDA for PW2101
June 29	Merck Announces that FDA Has Accepted For Review Biologics License Applications for Rotateq and Zostavax
June 29	Merck Announces that FDA Has Accepted For Review Biologics License Applications for Rotateq and Zostavax
June 30	Genta Initiates New Drug Application for Genasense in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
June 30	Avanir Submits NDA for Neurodex
June 30	FDA Agrees to File and Review NDA for Fibrillex
June 30	Cellegy Reports Status of Response Date for FDA Review
June 30	Halozyme Therapeutics Announces Submission of Investigational New Drug Application
June 30	Takeda Submits New Drug Application for Combination Type 2 Diabetes Medication Containing Pioglitazone HCl and Glimepiride
June 30	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Receives Not Approvable Letter From FDA for Tipifarnib Based on Phase II Data

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