Endo Says FDA Accepts Application For Nebido
CHADDS FORD, Pa. (AP) ¿ The Food and Drug Administration accepted Endo Pharmaceuticals Holdings Inc.'s application for the testosterone drug candidate Nebido, Endo said Thursday.
The FDA accepted a New Drug Application for Nebido and intends to rule on the drug by Sept. 2. The U.S. rights to the drug are held by Indevus Pharmaceuticals Inc., which was bought by Endo earlier this year.
Nebido is a long-lasting injection designed to treat hypogonadism, a hormonal condition that interferes with the functioning of the testes. The drug is already approved in Europe, where it is marketed by BayerSchering.
Endo shares slipped 13 cents to $16.52 in midday trading, and Indevus shares gained 6 cents to $5.77.
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