Biotech firm Clarus Therapeutics resubmitted its New Drug Application (NDA) for Jatenzo, an oral version of testosterone, hoping the drug will become the first oral testosterone product on the market. Clarus has been in a head-to-head race with Lipocine Inc.’s LPCN 1021 to gain Food and Drug Administration (FDA) approval for an oral testosterone treatment. Lipocine’s bid for FDA clearance was shot down in early 2016 after regulators questioned the dosing algorithm. The company responded by submitting a new dosing validation study protocol, which the FDA reviewed and approved. That study is currently underway. The NDA for Jatenzo was initially submitted ... Read More
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