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Lipocine Says FDA Affirms Class 1 NDA Resubmission For TLANDO - Quick Facts

Biopharmaceutical company Lipocine Inc. (LPCN) announced Tuesday that the U.S. Food and Drug Administration has affirmed the resubmission of its New Drug Application or NDA for TLANDO, its oral testosterone product, will be a Class 1 resubmission.

A Class 1 NDA resubmission includes a two-month FDA review goal period. The FDA granted tentative approval to TLANDO in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone in December 2020.

In granting tentative approval, the FDA concluded that TLANDO met required quality, safety and efficacy standards necessary for approval.

However, the product was not granted final approval and is not eligible for final approval and marketing in the U.S. until the expiration of the FDA's Orange Book listed exclusivity period previously granted to Clarus Therapeutics, Inc. with respect to Jatenzo, which expires on March 27, 2022.

The resubmission of the NDA is a necessary requirement to receive final approval from the FDA and is expected to occur on January 28, 2022, based on the FDA's Class 1 affirmation.

Lipocine said it believes that TLANDO represents a differentiated testosterone replacement therapy for treating hypogonadism in men. It has the potential to both improve patient compliance and overcome inadvertent testosterone transference and pulmonary oil micro-embolism risks, effects often associated with existing non-oral treatments.

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