(Adds details, background, shares)
March 6 Endo International Plc said the
U.S. Food and Drug Administration approved its thrice-rejected
testosterone replacement therapy, Aveed, to treat male
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
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
Endo International, formerly known as Endo Health Solutions
Inc, said it expected to launch Aveed in early March.
The Dublin-based company said on Feb. 28 that it would
change its name following its acquisition of Paladin Labs.
Endo International's shares closed at $76.47 on the Nasdaq
(Reporting by Natalie Grover and Vrinda Manocha in Bangalore;
Editing by Kirti Pandey)