FDA Accepts Complete Response Submission to New Drug Application for... ( CHADDS FORD Pa. March 12 /- Endo Phar...)

FDA Accepts Complete Response Submission to New Drug Application for NEBIDO(R)

Date:3/12/2009

CHADDS FORD, Pa., March 12 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) and its majority-owned subsidiary Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the complete response submission to the new drug application for NEBIDO(R) (testosterone undecanoate) intramuscular injection, an investigational testosterone preparation for the treatment of male hypogonadism. FDA is targeting September 2, 2009 as the action date for a decision on this application.

Endo's president and CEO, David Holveck, stated: "We are pleased with the FDA's action and congratulate the NEBIDO development team on reaching this milestone. We look forward to receiving the FDA's decision on the NEBIDO marketing application in September."

About NEBIDO

NEBIDO is a novel, long-acting injectable testosterone preparation for the treatment of male hypogonadism. NEBIDO was licensed by BayerSchering Pharma AG to Indevus Pharmaceuticals, a majority interest in which Endo acquired earlier this year. If approved, NEBIDO is expected to be the first long-acting testosterone preparation available in the U.S. in the growing market for testosterone replacement therapies. NEBIDO is currently marketed by BayerSchering and its partners in Europe and other territories.

About Hypogonadism

Male hypogonadism is an increasingly recognized medical condition characterized by a reduced or absent secretion of testosterone from the testes. Reduced testosterone levels can lead to health problems and significantly impair quality of life. Common effects of hypogonadism include decreased sexual desire, erectile dysfunction, musc
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SOURCE Endo Pharmaceuticals
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