Business
Lipocine Announces FDA Affirmation Of Class 1 NDA Resubmission For TLANDO®
SALT LAKE CITY, Sept. 28, 2021 /PRNewswire/ -- Lipocine Inc. (Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine
About this update from Lipocine Inc.
[{"type":"text","content":"SALT LAKE CITY, Sept. 28, 2021 /PRNewswire/ -- Lipocine Inc. (Nasdaq: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the U.S. Food and Drug Administration (\"FDA\") has affirmed the resubmission of its New Drug Application (\"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: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired) in December 2020. In granting tentative approval, the FDA concluded that TLANDO met required quality, safety and efficacy standards necessary for approval, but 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. 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.\n\n \n \n \n \n \n \n\n \n\"We are pleased that the FDA has affirmed the resubmission of the NDA for TLANDO will be a Class 1 resubmission,\" said Dr. Mahesh Patel, Chairman, President, and Chief Executive Officer of Lipocine. \"We believe 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.\"\nAbout LipocineLipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148, LPCN 1154, and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, ...