FDA provides tentative approval of Tlando to treat testosterone deficiency.- Lipocine Inc.

Lipocine Inc. announced that the FDA has granted tentative approval to Tlando, its oral testosterone product for testosterone replacement therapy ("TRT") in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). In granting tentative approval, the FDA has concluded that Tlando has met all required quality, safety and efficacy standards necessary for approval, but Tlando has not received final approval and is not eligible for final approval and marketing in the U.S. until the expiration of the exclusivity period previously granted to Clarus Therapeutics, Inc. with respect to Jatenzo, which expires on March 27, 2022. Lipocine is currently reviewing FDA's tentative approval of Tlando and remains committed to taking appropriate actions with the goal of receiving final approval to permit the launch of Tlando. The FDA has also required Lipocine to conduct certain post-marketing studies to (i) assess patient understanding of key risks relating to Tlando and (ii) evaluate development of adrenal insufficiency with chronic Tlando therapy.