Mar 06, 2014 02:02 PM EST By Jaleesa Baulkman, UniversityHerald Reporter

Endo International Plc announced Thursday that the U.S. health regulators approved its thrice-rejected testosterone replacement therapy, Reuters reported.

AVEED, a new prescription medicine, is used to treat male hypogonadism - a disease associated with a deficiency or absence of the male hormone testosterone. The drug is indicated to produce serum testosterone levels in the normal range by administration of a single 3-mL (750 mg) intramuscular injection given once at initiation of therapy, at 4 weeks, and then every 10 weeks thereafter.

"Today's FDA approval of AVEED is a significant milestone for Endo. AVEED expands our branded portfolio of men's health products and highlights our passion and commitment to providing high quality therapies that improve patient care," Rajiv De Silva, president and chief executive officer of Endo, said in a statement. "With AVEED, Endo can now offer men living with hypogonadism different treatment options to raise testosterone levels. We are focused on getting AVEED to market to ensure that appropriate patients have access to it."

The treatment was rejected by health regulators in May because Endo lacked a better plan to manage risks associated with the long-acting drug that contains testosterone and castor oil, Reuters reported.

The approval of the prescription drug is based on data from an 84-week Phase 3 trial of hypogonadal men in the United States. Men enrolled in the study had an average age of 54 years and a serum total testosterone level of less than 300 ng/dL. In the study, AVEED increased mean serum testosterone levels, maintaining them for up to 10 weeks at steady state between weeks 14-24.

Endo International Plc's Aveed is expected to be available in early March.

See Now: Covert Team Inside Newsweek Revealed as Key Players in False Human Trafficking Lawsuit