The FDA has informed Lipocine (NASDAQ:LPCN) that it needs more time to complete its review of the company’s marketing application for oral testosterone replacement therapy Tlando (testosterone undecanoate). The agency’s action date was today.
Management says the FDA did not provide a new action date but stated that the review should wind up in the coming weeks. It did not request additional data.
Nothing has been easy for the company in its registration efforts. It received a third Complete Response Letter (CRL) in November 2019 after previous CRLs in June 2016 and May 2018.
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