FDA to review drug by Endo Pharmaceuticals

CHADDS FORD, Pa. Endo Pharmaceuticals, and its majority-owned subsidiary Indevus Pharmaceuticals, Inc., announced Thursday that the Food and Drug Administration will review its intramuscular injection medication for marketing approval.

Endo submitted a new drug application for NEBIDO (testosterone undecanoate), an investigational testosterone preparation for the treatment of male hypogonadism.

FDA is targeting Sept. 2, 2009 as the action date for a decision on this application.

“We are pleased with the FDA’s action and congratulate the NEBIDO development team on reaching this milestone,” said David Holveck, president, CEO Endo Pharmaceuticals. “We look forward to receiving the FDA’s decision on the NEBIDO marketing application in September.”