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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
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
Epix Pharmaceuticals to File Appeal with the Center for Drug Evaluation and Research for Vasovist
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
December 15
Genta Receives Non-Approvable Notice for Application of Genasense in Patients With Chronic Lymphocytic Leukemia
New Drug Application Submitted for Investigational Antibiotic Doripenem
Roche Offers the FDA Additional Mircera Data
Encysive Pharmaceuticals Submits Response to FDA For Thelin New Drug Application
December 18
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
FDA Grants Torisel NDA Priority Review Status
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
Genzyme Files for Approval of Sevelamer Carbonate for Patients on Dialysis
Allergan Announces FDA Issues Approvable Letter for Combigan 0.2%/0.5%
December 22
GSK Receives Approvable Letter for Topical Antibiotic, Altabax (retapamulin ointment), 1%
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 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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