IntelGenx announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed, has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its resubmitted abbreviated new drug application for Buprenorphine Buccal Film. The CRL includes a request for additional Pharmaceutical Quality information. The FDA confirmed that no additional inspection of IntelGenx’s facility is required at this time.
Confident Investing Starts Here:
- Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions
- Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on IGXT:
- IntelGenx Foresees Revenue Growth with RIZAFILM Launch
- IntelGenx reports Q4 EPS (1c) vs (1c) last year
- IntelGenx Reports Fourth Quarter and Full-Year 2023 Financial Results
- IntelGenx Set to Unveil 2023 Financial Results
- IntelGenx to Report Fourth Quarter and Full Year 2023 Financial Results on March 21, 2024 – Conference Call to Follow
Looking for a trading platform? Check out TipRanks' Best Online Brokers guide, and find the ideal broker for your trades.
Report an Issue