New Drug Applications Archive

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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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