Regulatory Guidance / Drug Approvals

FDA hands 3rd denial to Lipocine testosterone med

Nov 11, 2019

The third time was not the charm for Lipocine’s male sex hormone treatment. For the third time, the FDA has opted not to approve the drug, Tlando, which was developed help give a testosterone boost to men with a deficiency. Low testosterone levels impact an estimated 21.7 million American men between the ages of 30 and 79.

The company reported the regulatory update in a letter, saying that the agency decided not to approve the treatment because the most recent trial failed to meet three secondary goals related to understanding the safety of higher testosterone levels in men. 

Past denials of Tlando were handed out by the FDA in 2016 and 2018. In those instances, the agency had concerns over dosing inconsistencies and questions about whether or not the treatment raised blood pressure levels.

Lipocine said it will work with the FDA again to address the latest issues. The company is hoping its drug can compete with approved topical treatments that run the risk of medication transference.

Read the Reuters report.