New Drug Applications Archive - December 2006
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December 1, 2006
December 8, 2006
December 12, 2006
- U.S. Food and Drug Administration Files New Drug Application for Bifeprunox, Submitted in October 2006
- VIVUS Announces FDA Acceptance of EvaMist NDA Submission
December 13, 2006
December 14, 2006
- Novartis Announces Three-Month Extension of US Regulatory Review Period for Tekturna
- Encysive Expects to Submit Revised Response to Thelin Approvable Letter Within Several Days
- Epix Pharmaceuticals to File Appeal with the Center for Drug Evaluation and Research for Vasovist
December 15, 2006
- New Drug Application Submitted for Investigational Antibiotic Doripenem
- Roche Offers the FDA Additional Mircera Data
- Genta Receives Non-Approvable Notice for Application of Genasense in Patients With Chronic Lymphocytic Leukemia
- Encysive Pharmaceuticals Submits Response to FDA For Thelin New Drug Application
December 18, 2006
- ZymoGenetics Submits BLA to the FDA for rhThrombin as an Aid to Controlling Bleeding During Surgery
- Cardiome and Astellas Pharma US, Inc. Announce Re-Submission of NDA for Vernakalant (IV)
December 19, 2006
- Gilead Submits NDA To U.S. FDA for Ambrisentan for the Treatment of Pulmonary Arterial Hypertension
- FDA Grants Torisel NDA Priority Review Status
December 21, 2006
- Genzyme Files for Approval of Sevelamer Carbonate for Patients on Dialysis
- New River Pharmaceuticals and Shire Receive Approvable Letter for Vyvanse
- Allergan Announces FDA Issues Approvable Letter for Combigan 0.2%/0.5%
December 22, 2006
- Pharmacyclics Submits NDA for Xcytrin for the Treatment of Lung Cancer Brain Metastases
- GSK Receives Approvable Letter for Topical Antibiotic, Altabax (retapamulin ointment), 1%
