Lipocine Inc. announced that Antares Pharma, Inc. issued a release announcing that the U.S. Food and Drug Administration has accepted its New Drug Application resubmission for TLANDO (testosterone undecanoate). The FDA designated the NDA as a Class 1 resubmission with a two-month review goal period and set a target action date of March 28, 2022, under the Prescription Drug User Fee Act (PDUFA). Lipocine licensed the exclusive U.S. rights for TLANDO to Antares Pharma.

The FDA previously granted tentative approval for TLANDO, an oral treatment for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. In granting tentative approval, the FDA concluded that TLANDO met all required quality, safety, and efficacy standards necessary for approval and will be eligible for final approval and marketing in the U.S. upon expiration of the exclusivity period previously granted to Clarus Therapeutics, Inc. for JATENZO on March 27, 2022.