New Drug Applications Archive

New Drug Applications: December 2006

December 1	Merck Announces Janumet, the Trademark for its Investigational Combination Therapy of Sitagliptin Phosphate and Metformin for Type 2 Diabetes
December 8	Rimonabant Update in the United States
December 12	U.S. Food and Drug Administration Files New Drug Application for Bifeprunox, Submitted in October 2006
December 12	VIVUS Announces FDA Acceptance of EvaMist NDA Submission
December 13	Pozen Expects to Submit Revised Response to Trexima Approvable Letter by Year End
December 14	Encysive Expects to Submit Revised Response to Thelin Approvable Letter Within Several Days
December 14	Epix Pharmaceuticals to File Appeal with the Center for Drug Evaluation and Research for Vasovist
December 14	Novartis Announces Three-Month Extension of US Regulatory Review Period for Tekturna
December 15	Genta Receives Non-Approvable Notice for Application of Genasense in Patients With Chronic Lymphocytic Leukemia
December 15	Encysive Pharmaceuticals Submits Response to FDA For Thelin New Drug Application
December 15	New Drug Application Submitted for Investigational Antibiotic Doripenem
December 15	Roche Offers the FDA Additional Mircera Data
December 18	Cardiome and Astellas Pharma US, Inc. Announce Re-Submission of NDA for Vernakalant (IV)
December 18	ZymoGenetics Submits BLA to the FDA for rhThrombin as an Aid to Controlling Bleeding During Surgery
December 19	FDA Grants Torisel NDA Priority Review Status
December 19	Gilead Submits NDA To U.S. FDA for Ambrisentan for the Treatment of Pulmonary Arterial Hypertension
December 21	New River Pharmaceuticals and Shire Receive Approvable Letter for Vyvanse
December 21	Allergan Announces FDA Issues Approvable Letter for Combigan 0.2%/0.5%
December 21	Genzyme Files for Approval of Sevelamer Carbonate for Patients on Dialysis
December 22	GSK Receives Approvable Letter for Topical Antibiotic, Altabax (retapamulin ointment), 1%
December 22	Pharmacyclics Submits NDA for Xcytrin for the Treatment of Lung Cancer Brain Metastases
December 26	IDM Pharma Announces Acceptance for Review of the NDA for Junovan (Mifamurtide)
December 27	Adams Respiratory Therapeutics Seeks Approval for New Prescription Cough Suppressant
December 27	Adams Respiratory Therapeutics Seeks Approval for New Prescription Cough Suppressant
December 28	FDA Accepts Encysive’s Complete Response to Thelin New Drug Application
December 29	Nuvo Receives Approvable Letter From U.S. FDA for Pennsaid

New Drug Applications Archive

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