Sun Pharma's Licensing Partner Receives FDA Complete Response Letter for PDP-716 NDA
Sun Pharma Advanced Research Company Ltd. has reported that its licensing partner, Ocuvex Therapeutics Inc., has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). The update concerns the PDP-716 New Drug Application (NDA).The CRL was issued by the FDA following inspection findings at the finished product manufacturing facility for the drug application.
According to the information released by Sun Pharma Advanced Research Company Ltd., the FDA did not raise any other issues with the PDP-716 NDA, indicating that the sole cause for the Complete Response Letter was the inspection findings.
SPARC Stock Price Movement
On Tuesday, Sun Pharma Advanced Research Company Limited shares edged higher to close at ₹179.77, having gained 10.95% on the day. The stock rallied on strong conviction, achieving a substantial total traded volume of 43.11 million shares.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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