LPCN - Lipocine announces FDA accepted the marketing application for Tlando

Lipocine (LPCN) shares are trading higher after announcing that the FDA accepted the New Drug Application ("NDA") resubmission for Tlando (testosterone undecanoate), a potential rival for Jatenzo from Clarus Therapeutics (NASDAQ:CRXT). The federal agency has designated the marketing application as a Class 1 resubmission with a review period of two months and a target action date of March 28. The company has licensed the exclusive U.S. rights for Tlando to Antares Pharma. The FDA has previously issued a tentative approval for TLANDO, an oral testosterone replacement therapy for conditions linked to hypogonadism (deficiency of testosterone hormone). Following the tentative approval, Lipocine (NASDAQ:LPCN) became eligible for the final approval and U.S. marketing of the drug once the current exclusivity period granted to Clarus (CRXT) for Jatenzo ends on March 27.

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Lipocine announces FDA accepted the marketing application for Tlando