FDA declines to approve hypogonadism treatment

CHADDS FORD, Pa. The Food and Drug Administration declined to approve an injected drug from Endo Pharmaceuticals designed to treat men with low testosterone, a condition known as hypogonadism, Endo announced Thursday.

The drug maker said it received a complete response letter – a notice that the FDA is not prepared to approve a drug – requesting information to address the agency’s concerns about potentially serious side effects in patients taking the drug Aveed (testosterone undecanoate), including anaphylactic response and telling Endo that the proposed Risk Evaluation and Mitigation Strategy, also known as REMS, is insufficient.

Endo said it was evaluating the letter.