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Lipocine's application for hypogonadism treatment accepted by FDA

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.