New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

January 2005

January 3

Dacogen NDA Accepted for Filing by FDA Insmed Submits New Drug Application -NDA- to Seek Regulatory Approval of SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome SuperGen Announces Withdrawal of Orathecin NDA

January 5

H3 Pharma Receives Approvable Letter from FDA for Sanvar for Esophageal Variceal Bleeding Valeant Pharmaceuticals Submits Complete Response to FDA Approvable Letter for Zelapar

January 6

Savient Pharmaceuticals, Inc. Submits New Drug Application for Soltamox to the U.S. Food and Drug Administration

January 7

Berlex Receives Approvable Letter for Bonefos (Clodronate) for Adjuvant Treatment of Breast Cancer

January 10

Adolor Announces FDA Update

January 11

Neurocrine Biosciences Announces Plans to Resubmit Indiplon Modified Release New Drug Application (NDA)

January 14

FDA has completed its review of the NDA for MS-325

January 18

Orphan Medical Submits Xyrem sNDA to Include Improvement in Other Primary Symptoms of Narcolepsy

January 19

FDA Issues Not Approvable Letter for Marqibo

January 24

Johnson & Johnson Completes Submission of Tipifarnib NDA to FDA

January 28

Schwarz Pharma Re-Submits NDA for Rotigotine in the U.S. FDA Grants Tygacil (Tigecycline) NDA Priority Review Status

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