CHADDS FORD, Pa. (AP) — The FDA has extended a review of a testosterone drug candidate by three months, the product's maker, Endo Pharmaceuticals Holdings Inc., said Wednesday.
The FDA extended its review period to Dec. 2. The review had been scheduled to end Sept. 2. Endo said the agency needs more time to review the application and complete a risk evaluation and mitigation strategy, but has not asked for more data about the drug.
The drug is a long-acting testosterone undecanoate injection intended to treat hypogonadism, which is a hormonal condition that interferes with the functioning of the testes. The injection is sold outside the U.S. as Nedibo. It was discovered and developed by Bayer Schering Pharma AG, licensed to Indevus Pharmaceuticals Inc.
Endo bought Indevus earlier this year.