Oral Testosterone Battle Looms As Lipocine's Tlando Joins Clarus' Jatenzo In US FDA Review Queue
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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Tlando's product would offer convenient oral route of administration, but may carry some secondary (endpoint) problems.
US FDA questions Clarus product's long-term safety in briefing documents for Bone, Reproductive and Urologic Drugs Advisory Committee meeting.
Keeping Track: A Burst of CRLs and BTDs, A Busy Week Of Submissions And Another Approval For Soliris
The latest drug development news and highlights from our US FDA Performance Tracker.