Endo responds to FDA Complete Response letter for FORTESTA NDA

Published July 2, 2010

Endo responds to FDA Complete Response letter for FORTESTA NDA
Endo Pharmaceuticals has submitted a complete response to the U.S. Food and Drug Administration (FDA) following the company’s receipt of a Complete Response letter in October 2009 related to the New Drug Application (NDA) submission for FORTESTA™ (testosterone) 2% gel. The company’s Class 2 resubmission is the next step in its intention to offer FORTESTA as a treatment option in the United …
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