SPARC announces US FDA acceptance of NDA for Taclantis

摘要

Sun Pharma Advanced Research Company Ltd. (SPARC) has announced that the 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.