Oral Testosterone Battle Looms As Lipocine's Tlando Joins Clarus' Jatenzo In US FDA Review Queue
Executive Summary
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.
You may also be interested in...
Lipocine Testosterone Therapy Faces Safety, Stopping Criteria Concerns At US FDA Advisory Cmte
Tlando's product would offer convenient oral route of administration, but may carry some secondary (endpoint) problems.
Oral Testosterone Therapy Jatenzo Faces CV, Sampling Tube Issues At Advisory Cmte
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.