FDA CRL - CIPLA USA INC

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Cipla USA, Inc., on March 22, 2024, regarding its New Drug Application (NDA 210168). The FDA determined that the application for a new drug cannot be approved in its present form. The primary reason for the non-approval is due to deficiencies identified during a recent surveillance inspection of a manufacturing facility associated with the application. The FDA has communicated these issues to the facility’s representatives, and the satisfactory resolution of these findings is a prerequisite for the NDA’s approval. Cipla USA, Inc. is required to address all identified deficiencies and either resubmit the application or take other available actions within one year, as stipulated by regulatory guidelines (21 CFR 314.110). Any resubmission must be clearly marked as such and comprehensively address all points raised in the CRL; a partial response will not be processed as a resubmission. The company may also request a meeting or teleconference with the FDA to discuss the necessary steps for moving forward with the application.