Posted by Michael Wonder on 18 Nov 2017
U.S. FDA extends review for Tlando; Advisory Committee meeting date of 10 January 2018 remains unchanged
17 November 2017 - Lipocine today announced the U.S. FDA has extended the review period for the new drug application for Tlando, the company's oral testosterone product candidate for the proposed indication of testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
The FDA has assigned a new Prescription Drug User Fee Act goal date of 8 May 2018.
