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Oral Testosterone Battle Looms As Lipocine's Tlando Joins Clarus' Jatenzo In US FDA Review Queue

 
• By Bridget Silverman

Lipocine resubmits Tlando NDA with new study data supporting twice-daily fixed dosing regimen for the oral testosterone replacement candidate; FDA action expected by Feb. 8.

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Second-cycle reviews are now underway for two competing oral testosterone replacement candidates with the recent resubmission of Lipocine Inc.'s Tlando. Clarus Therapeutics Inc. resubmitted its oral testosterone formulation Jatenzo in June.

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