USFDA19 May 2026, 06:51 pm
Sun Pharma Advanced Research: PDP-716 NDA Receives CRL from US FDA
AI Summary
Sun Pharma Advanced Research Company Ltd announced that its licensing partner, Ocuvex Therapeutics Inc., received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for PDP-716. The CRL was issued due to inspection findings at the finished product manufacturing facility. The FDA did not raise any other issues with the PDP-716 NDA.
Key Highlights
- Ocuvex Therapeutics received a CRL from the FDA for PDP-716 NDA.
- The CRL was due to inspection findings at the manufacturing facility.
- FDA did not raise other issues with the PDP-716 NDA.