Endo’s testosterone replacement Aveed gets FDA approval

Endo International (Nasdaq: ENDP) says its operating company Endo Pharmaceuticals has received US Food and Drug Administration approval of Aveed (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone. Endo’s shares closed up 3.4% at $73.89.

Aveed, which was previously rejected by the FDA (The Pharma Letter May 31, 2013), is a new prescription medicine indicated to produce serum testosterone levels in the normal range by administration of a single 3-mL (750mg) intramuscular injection given once at initiation of therapy, at four weeks, and then every 10 weeks thereafter. It is expected to be available in early March.

"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," said Rajiv De Silva, president and chief executive of Endo.