Sun Pharma Advanced Research partner receives FDA response on PDP-716 application

Arunika Jain — Tue, 19 May 2026 13:15:27 +0000

Sun Pharma Advanced Research Company (SPARC) has announced that its licensing partner, Ocuvex Therapeutics Inc., has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) concerning the New Drug Application (NDA) for PDP-716. The CRL was issued following inspection findings at the finished product manufacturing facility. Importantly, the FDA did not identify any other issues with the PDP-716 NDA.

This development is part of the regulatory process where the FDA communicates its findings and any necessary actions required before approval can be granted. The CRL indicates that while there are no additional concerns with the NDA itself, the issues at the manufacturing facility need to be addressed to meet the FDA’s standards.

Sun Pharma Advanced Research Company, known for its focus on pharmaceutical research and development, is working closely with Ocuvex Therapeutics to resolve the matters raised by the FDA. The company aims to address the inspection findings promptly to advance the approval process for PDP-716.

The issuance of a CRL is a common step in the drug approval process and provides the applicant with the opportunity to rectify identified issues. SPARC and its partner are expected to engage with the FDA to ensure compliance and move forward with the application.

Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).

Ocuvex Therapeutics | Business Upturn

Sun Pharma Advanced Research partner receives FDA response on PDP-716 application