Lipocine Says LPCN 1154 Met standard Bioequivalence (BE) Criteria; Co Says On Track For NDA Filing, Targeting Q4 2024
Benzinga Newsdesk 2 years ago
NewsFDA
Met standard bioequivalence (BE) criteria Cmax, AUC0-t, and AUC0-∞Ctrough criterion was metLPCN 1154 was well tolerated with no sedation or somnolence events observedOn track for NDA filing, targeted by end of Q4 2024
- Met standard bioequivalence (BE) criteria Cmax, AUC0-t, and AUC0-∞
- Ctrough criterion was met
- LPCN 1154 was well tolerated with no sedation or somnolence events observed
- On track for NDA filing, targeted by end of Q4 2024