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Ad Comm review approaches for Lipocine's oral testosterone replacement med Tlando; shares ahead 17%

Published 01/08/2018, 01:01 PM
© Reuters.  Ad Comm review approaches for Lipocine's oral testosterone replacement med Tlando; shares ahead 17%
LPCN
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  • The FDA's Bone, Reproductive and Urologic Drugs Advisory Committee will meet on Wednesday, January 10 to discuss Lipocine's (LPCN +16.5%) marketing application seeking approval for TLANDO (testosterone undecanoate) for the treatment of low testosterone in hypogonadal males.
  • The advisory committee will meet tomorrow to discuss the marketing application from competitor Clarus Therapeutics for JATENZO (testosterone undecanoate) for the same indication.
  • FDA briefing doc
  • Errata to FDA briefing doc
  • Lipocine briefing doc
  • Previously: Ad Com next week for Clarus Therapeutics' oral testosterone (Jan. 5)
  • Now read: Your Daily Pharma Scoop: Lipocine Ahead Of Ad Com, Ohr's MAKO Study Fails, Zafgen Provides Update


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