Lipocine Inc. said the U.S. Food and Drug Administration accepted the new drug application for its oral testosterone candidate, Tlando, used to treat hypogonadism.
Hypogonadism is a form of testosterone deficiency in adult males.
The company resubmitted its application Aug. 9, following a complete response letter from the FDA in June 2016 that requested additional information on the drug's dosing algorithm. The company resubmitted the application after completing a dosing validation study.
The FDA is expected to make a decision Feb. 8, 2018.