MALVERN, Pa. (AP) -- Endo Health Solutions Inc. said Thursday the Food and Drug Administration wants more information about its long-acting testosterone injection Aveed before it will approve the drug.
Endo said the FDA is concerned about risks and severe complications related to post-injection reactions. Endo said it is being asked to develop a medication guide and take other steps to make sure the drug is prescribed, dispended, and used safely. It said the agency did not ask it to run any new clinical studies, which might lead to big expenses and longer delays. Endo said it plans to submit a response by the end of September.
Endo has asked the FDA to approve its drug as a long-lasting treatment for hypogonadism, which is characterized by abnormally low testosterone levels. Low testosterone levels are associated with fatigue, weight gain, depressed mood and reduced libido. Aveed is intended to be injected once every 10 weeks.
In April a panel of FDA advisers voted 9-9 on the drug's safety. The FDA has rejected Aveed twice in the past.
Endo shares rose 49 cents to $35.94 on Thursday. The shares fell 2 cents to $35.92 in aftermarket trading.