Endo Pharmaceuticals (Nasdaq: ENDP) announced today that it has been informed by the U.S. Food and Drug Administration (FDA) that the agency has extended its review period for its long-acting testosterone undecanoate injection for men diagnosed with hypogonadism, from Sept. 2, 2009 to Dec. 2, 2009.
While the FDA has not requested additional data, the agency has informed the company that it needs more time to complete its review of the application and finalize the risk evaluation and mitigation strategy (REMS) for this product.
"Our goal is to make this significant new treatment option available to the millions of men in the U.S. suffering from low testosterone," said David Holveck, president and chief executive officer of Endo Pharmaceuticals. "We believe our application fully supports the approval of this therapy, which will be an important step in filling a gap in testosterone therapy and improving patient care."
Endo Pharmaceuticals' long-acting testosterone undecanoate, known as Nebido(R) outside the U.S., was licensed by Bayer Schering Pharma AG, Germany to Indevus Pharmaceuticals, a company that Endo acquired earlier this year. Nebido, discovered and developed by Bayer Schering Pharma AG, Germany, has subsequently been approved in 86 countries worldwide and is available in more than 50 countries across Europe, Asia Pacific and Latin America.