New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

June 2005

June 1

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

Vicuron Pharmaceuticals Receives Issued Patent for Dalbavancin Dosing by U.S. Patent and Trademark Office 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 FDA Extends PDUFA Date for SomatoKine to October 3, 2005

June 13

U.S. FDA Agrees to Rolling New Drug Application for Virulizin 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 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 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 Penwest Receives Non-Approvable Letter from FDA for PW2101 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

Genta Initiates New Drug Application for Genasense in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia FDA Agrees to File and Review NDA for Fibrillex Halozyme Therapeutics Announces Submission of Investigational New Drug Application Takeda Submits New Drug Application for Combination Type 2 Diabetes Medication Containing Pioglitazone HCl and Glimepiride Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Receives Not Approvable Letter From FDA for Tipifarnib Based on Phase II Data Avanir Submits NDA for Neurodex Cellegy Reports Status of Response Date for FDA Review

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