The Food and Drug Administration has for the third time refused approval to Endo Health Solutions Inc's injectable testosterone drug Aveed, pressing for a still better plan to manage the risks associated with the drug.
The denial comes as no surprise after an advisory panel to the FDA overwhelmingly agreed in April that Endo's proposed plan for managing the risks associated with the drug was insufficient.
Testosterone, a hormone produced in the testicles, is responsible for maintaining muscle bulk, bone growth and sexual function. Lack of testosterone can lead to loss of libido, depression, decreased muscle mass and fatigue.
Aveed is made of testosterone and castor oil and the FDA has previously expressed concern of a risk that the oil could cause blockages in blood vessels in the lungs.
Lack of a suitable strategy to address these issues had led the FDA to refuse Aveed's marketing application the last two times.
On Thursday, Endo said the agency wants it to include a medication guide and other some additional elements to its risk mitigation strategy to ensure the safe use of the drug and to avoid severe complications related to post-injection reactions, the drugmaker said on Thursday.
It, however, did not ask Endo to perform an additional clinical study.
Endo added that it plans to respond to the FDA by the end of the third quarter of this year.
Endo's shares closed at $35.94 on Thursday on the Nasdaq and declined only marginally to $35.91 after market close.
(Reporting by Zeba Siddiqui in Bangalore; Editing by Sreejiraj Eluvangal)