The US Food and Drug Administration (FDA) has accepted for review the complete response submission made by Endo Health Solutions' subsidiary Endo Pharmaceuticals to the new drug application (NDA) for its testosterone undecanoate injection 'AVEED'.
Endo's testosterone undecanoate injection is intended for treatment of men diagnosed with hypogonadism, which occurs when the body's sex glands produce little or no hormones.
Hypogonadism is a diminished functional activity of the gonads that may result in diminished sex hormone biosynthesis and impaired gamete production and/or regulation.
The FDA has also assigned Endo's NDA, a new Prescription Drug User Fee Act (PDUFA) action date of 28 February 2014.
Endo executive vice president of research and development and chief scientific officer Ivan Gergel said, "We look forward to working with the FDA to complete the review process and make this treatment option available to appropriate male patients in the U.S. diagnosed with hypogonadism."
