Sun Pharma Advanced Research Company (SPARC) has received a Complete Response Letter (CRL) from the United States Food & Drug Administration (USFDA) for the New Drug Application (NDA) for Taclantis (Paclitaxel Injection Concentrate for Suspension).
The company is reviewing the CRL and intends to work with the USFDA as soon as possible to address the concerns raised. As per the USFDA, a CRL is sent to an applicant if the agency determines that it will not approve the application or abbreviated application in its present form.
SPARC is an international pharmaceutical company engaged in research and development of drugs and delivery systems.
