US FDA denies Clarus' oral testosterone ester Citizen Petition, says Lipocine
US drug developer Lipocine (Nasdaq: LPCN) today announced that the US Food and Drug Administration denied the Citizen Petition filed by Clarus Therapeutics on October 2, 2019.
News of the rejection saw Lipocine’s shares fall 7% pre-market, but the stock was registering a near 2.5% gain to $0.59 by 09.54 local time
Specifically, the FDA declined to issue product-specific guidance on oral T-ester drug products and denied without comment Clarus' request regarding how the FDA should review and make approval decisions on any pending or future oral T-ester products.
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