FDA extends review on Endo drug

Endo Pharmaceuticals Holdings Inc., Chadds Ford, said the U.S. Food and Drug Administration has extended a review period for Endo's testosterone drug Nebido until Dec. 2. The review period was to have ended yesterday.

Nebido is a long-acting injection to treat hypogonadism, or low testosterone. The company says 13.8 million American men have testosterone levels characterized as below normal. Its use has been approved in 86 countries, Endo said.

The FDA has not requested additional data, but it informed the company that it needs more time to complete its review of the application "and finalize the risk evaluation and mitigation strategy for this product," according to an Endo statement.

Wells Fargo told investors in a Wednesday note: "The slight delay is not unexpected, as the FDA has pushed back dates for multiple drugs in the past 12 months."

"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 chief executive David Holveck said in the company statement.

Endo shares were down 35 cents, or 1.60 percent, to $21.47 in midday trading.    - Reid Kanaley