SALT LAKE CITY, Nov. 08, 2016 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced financial and operational results for the quarter ended September 30, 2016.
Quarterly and Recent Highlights
* Completed a Post Action meeting with the U.S. Food and Drug Administration ("FDA") regarding its 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, also known as hypogonadism. The purpose of the meeting was to review the previously received Complete Response Letter ("CRL") and to determine actions needed to achieve approval of LPCN 1021. Lipocine has submitted a new dosing validation clinical study protocol to the FDA and the FDA has agreed to review the protocol through a Special Protocol Assessment ("SPA").
Quarterly and Recent Highlights
* Completed a Post Action meeting with the U.S. Food and Drug Administration ("FDA") regarding its 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, also known as hypogonadism. The purpose of the meeting was to review the previously received Complete Response Letter ("CRL") and to determine actions needed to achieve approval of LPCN 1021. Lipocine has submitted a new dosing validation clinical study protocol to the FDA and the FDA has agreed to review the protocol through a Special Protocol Assessment ("SPA").
