LPCN - FDA Ok's Lipocine's testosterone replacement therapy tentatively

The FDA has granted tentative approval to Lipocine's (LPCN) Tlando, its oral testosterone product for testosterone replacement therapy in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary and hypogonadotropic hypogonadismThe agency cited that Tlando is not eligible for final approval and marketing in the U.S. until the expiration of the exclusivity period previously granted to Clarus Therapeutics for Jatenzo, which expires on March 27, 2022.The FDA has also required Lipocine to conduct certain post-marketing studies.Shares slips 15% in premarket.

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FDA Ok's Lipocine's testosterone replacement therapy, tentatively