USFDA accepts to review SPARC’s NDA for Taclantis
1st Jul 2019

The US Food and Drug Administration (USFDA) has accepted for review Sun Pharma Advanced Research Company’s (SPARC) New Drug Application (NDA) for Taclantis (Paclitaxel Injection Concentrate for Suspension). The NDA filing is based on successful demonstration of clinical bioequivalence of Taclantis with Abraxane and associated clinical safety data. SPARC seeks the same indications as Abraxane for Taclantis in the NDA. The USFDA confirmed that this NDA will be a standard review.

SPARC is an international pharmaceutical company engaged in research and development of drugs and delivery systems.