SPARC Announces U.S. FDA Acceptance of NDA for Taclantis (Paclitaxel Injection Concentrate for Suspe

SPARC Announces U.S. FDA Acceptance of NDA for Taclantis (Paclitaxel Injection Concentrate for Suspe

Sun Pharma Advanced Research Company Ltd. (SPARC) has announced that the U.S. Food and Drug Administration (USFDA) has accepted for review SPARC’s 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. About Taclantis (Paclitaxel Injection Concentrate for Suspension): Taclantis (Paclitaxel Injection Concentrate for Suspension) is a Cremophor® and Albumin-free formulation of Paclitaxel. It should be diluted with an appropriate volume of 5% w/v Dextrose injection in either a PVC or non-PVC type sterile infusion bag. Premedication to prevent hypersensitivity is generally not needed prior to administration of TaclantisTM.