CHADDS FORD, PA, USA (Press Release) - March 12, 2009 /PRNewswire-FirstCall via COMTEX/ - 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^® (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, muscle loss and weakness, depression, as well as an increased risk of osteoporosis. Today, there are an estimated four to five million men in the U.S. suffering from hypogonadism, of whom fewer than ten percent are receiving treatment with testosterone replacement therapy. The market is highly under-treated and is expected to grow by more than 10% annually. The U.S. market has experienced rapid growth to approximately $675 million in 2007.

About Endo

Endo Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development, sale and marketing of branded and generic prescription pharmaceuticals used primarily to treat and manage pain. Its products include LIDODERM^®, a topical patch to relieve the pain of postherpetic neuralgia; PERCOCET^® and PERCODAN^® tablets for the relief of moderate-to-moderately severe pain; FROVA^® tablets for the acute treatment of migraine attacks with or without aura in adults; OPANA^® tablets for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate; OPANA^® ER tablets for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time; and VOLTAREN^® gel, a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment. The company markets its branded pharmaceutical products to physicians in pain management, neurology, surgery, oncology, and primary care. More information, including this and past press releases of Endo Pharmaceuticals, is available at www.endo.com.

About Indevus

Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the acquisition, development, and commercialization of products to treat conditions in urology and endocrinology. The Company's approved products include SANCTURA^® and SANCTURA XR^™ for overactive bladder, VANTAS^® for advanced prostate cancer, SUPPRELIN^® LA for central precocious puberty, and DELATESTRYL^® to treat male hypogonadism. The Indevus development pipeline contains multiple compounds within the Company's core therapeutic areas in addition to several partnered or partnerable programs. The most advanced compounds in development include, VALSTAR^™ for bladder cancer, NEBIDO^® for hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, the octreotide implant for acromegaly and carcinoid syndrome, and pagoclone for stuttering.

Endo Pharmaceuticals

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