Endo International Plc said the U.S. Food and Drug Administration approved its thrice-rejected testosterone replacement therapy, Aveed, to treat male hypogonadism.
The company's shares rose 4.6 percent in premarket trading.
The regulator rejected the treatment last May, saying that the company needed a better plan to manage risks associated with the long-acting drug that contains testosterone and castor oil.
The FDA had expressed concerns about the risk of the castor oil in the formulation causing blockages in blood vessels in the lungs and of complications linked to post-injection reactions.
In February, a consumer advocacy group urged the FDA to delay its decision on Aveed, saying drugs treating low testosterone should carry strong warnings about the risk of heart problems.
Testosterone treatments currently include skin patches, short-acting injections and topical gels. AbbVie Inc's AndroGel, the market leader, generated about $1.2 billion in sales in 2012.
Male hypogonadism is characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth and sexual function. Low levels of testosterone can lead to a loss of libido, depression and fatigue.
Endo International, formerly known as Endo Health Solutions Inc, said it expected to launch Aveed in early March.
The Dublin-based company said on February 28 that it would change its name following its acquisition of Paladin Labs.
Endo International's shares closed at $76.47 on the Nasdaq on Wednesday.
(Reporting by Natalie Grover and Vrinda Manocha in Bangalore; Editing by Kirti Pandey)