New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

July 2006

July 6

Valera Pharmaceuticals Submits NDA for Supprelin-LA ISTA Pharmaceuticals Files NDA for T-Pred FDA Accepts Adeza NDA Filing for Gestiva to Prevent Preterm Births

July 10

FDA Issues Approvable Letter to Cellegy Pharmaceuticals for Cellegesic

July 12

GPC Biotech Submits Non-Clinical Section of Rolling NDA for Satraplatin

July 13

Nuvo’s Pennsaid NDA Resubmission Accepted for Review by U.S. FDA

July 17

Cangene’s Human Growth Hormone Drug Submission is Accepted for Review by FDA

July 18

Adeza Announces August 29 FDA Advisory Committee Date to Review Gestiva to Prevent Preterm Births

July 21

Shire Announces Filing of SPD465 for the Treatment of Adult ADHD

July 24

FDA Issues Approvable Letter for Thelin; One Outstanding Item Remains

July 27

Genta Announces FDA's Oncology Drug Advisory Committee Will Review Genasense as Treatment for Chronic Lymphocytic Leukemia UCB, Inc. Submits New Drug Application to FDA for Xyzal New Seasonal and Perennial Rhinitis Intranasal Treatment Submitted for U.S. and European Marketing Approval

July 28

FDA Extends Review of EPIX Pharmaceuticals’ Appeal of Vasovist Approvable Letters

July 31

Pozen to Submit Full Response to Trexima Approvable Letter During the Fourth Quarter Merck Announces FDA Acceptance of NDA for MK-0431A

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