Sun Pharma Advanced Research Company Ltd. announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for PDP-716 for the treatment of patients with Glaucoma, due to inspection findings at a third-party Active Pharmaceutical Ingredient (API) manufacturing facility. The FDA did not raise any issues with the PDP-176 clinical efficacy or safety and no additional clinical data or trials have been requested. SPARC is committed to work closely with Visiox, the FDA and the third-party manufacturer to resubmit the NDA as quickly as possible.
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5-day change | 1st Jan Change | ||
219 INR | +3.23% | -2.88% | -23.64% |
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+26.51% | 568B | |
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+3.73% | 284B | |
+16.70% | 240B | |
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-7.93% | 200B | |
-2.71% | 159B |
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- Sun Pharma Advanced Research Company Limited Announces That FDA Issues Complete Response Letter for Pdp-716 Nda Due to Inspection Findings At Third-Party Api Manufacturing Facility