14 August 2017 - Lipocine today announced that the U.S FDA has acknowledged receipt of the company's new drug application resubmission for Tlando, its oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. 

The FDA has deemed the resubmission a complete response to its June 2016 complete response letter that requested additional information related to the dosing algorithm for the proposed label. The FDA has assigned a new Prescription Drug User Fee Act goal date of 8 February 2018. 

The Tlando NDA is based on the results of the dosing validation study. The validation study confirmed the efficacy of Tlando with a fixed dose regimen without need for dose adjustment. Tlando was well tolerated upon 52 week exposure with no reports of drug related serious adverse events.

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