Endo International's Testosterone Drug Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved AVEED (TM) (testosterone undecanoate) injection for the treatment of adult men with hypogonadism, also known as Low-T or a deficiency in male testosterone. The drug, which is expected to be available in March, according to The Wall Street Journal, was approved on the fourth time around through the health organization, according to various reports.

The new prescription medicine works to produce serum testosterone levels in normal range through the administration of a single 3-mL (750 mg) intramuscular injection that's give once during the beginning of therapy, again 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," said Rajiv De Silva, president and chief executive officer of Endo, via The Wall Street Journal. "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."  

Studies showed that in the phase 3 trial of the drug, AVEED increase mean serum testosterone levels and helped them maintain these levels for up to 10 weeks.

This injection drug that is an androgen that works as a replacement therapy in adult males comes with a Boxed Warning regarding side effects, including the possibility of serious pulmonary microembolism (POME) reactions and anaphylaxis.

More information regarding the drug can be found here.