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 | ||
220.2 INR | +1.26% | -1.32% | -24.20% |
1st Jan change | Capi. | |
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-24.20% | 853M | |
+31.37% | 588B | |
-2.60% | 364B | |
+20.83% | 326B | |
+5.69% | 285B | |
+14.83% | 239B | |
+9.93% | 210B | |
-6.95% | 200B | |
+10.77% | 167B | |
+0.10% | 161B |
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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