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Lipocine Announces PDUFA Goal Date for LPCN 1021 NDA

SALT LAKE CITY, Nov. 12, 2015 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration ("FDA") has assigned a Prescription Drug User Fee Act ("PDUFA") goal date of June 28, 2016 for completion of the review of the New Drug Application ("NDA") for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency or absence of endogenous testosterone ("hypogonadism"). Additionally, the 74-day filing communication letter did not mention a need to convene an Advisory Committee for advice on the NDA for LPCN 1021 and we confirmed in subsequent communication with the FDA that an Advisory Committee is not planned.

About LPCN 1021

LPCN 1021 is a novel twice-a-day, oral testosterone replacement therapy product candidate with three simple oral dosing options that Lipocine expects will overcome the major shortcomings of existing products. The current testosterone market is dominated by topical products that carry FDA "black box" warnings related to inadvertent transfer of testosterone and by injectable products...


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