MALVERN, Pa. (AP) -- Endo Health Solutions said Thursday that regulators accepted for review new data for its long-acting testosterone injection Aveed and will make a ruling on the drug by Feb. 28.
The Food and Drug Administration asked Endo for more information in May. Endo said the FDA was concerned about risks and complications related to post-injection reactions. The agency also asked Endo to develop a medication guide and take other steps to make sure Aveed is prescribed, dispended, and used safely.
Endo wants to market Aveed as a 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.
The FDA has rejected Aveed twice, and in April an advisory panel voted 9-9 on the drug's safety.
Endo Health Solutions Inc. shares lost 3 cents to $43.03 in morning trading. They have been trading near the high end of their 52-week range of $25.01 to $43.18.