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SPARC gains on acceptance of NDA by USFDA

Nidhi Jani
/ Categories: DSIJ Mindshare
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SPARC gains on acceptance of NDA by USFDA

Sun Pharma Advanced Research Company (SPARC) informed the bourses that USFDA has accepted the company’s New Drug Application (NDA) for Taclanti (Paclitaxel Injection Concentrate for Suspension).

The company further informed that the new drug application filing is underpinned by the successful demonstration of clinical bioequivalence of Taclantis with Abraxane and associated clinical safety data. The company seeks the same indications as Abraxane for Taclanti in the NDA. The USFDA confirmed that this NDA will be a standard review.

Taclantis is a novel formulation of paclitaxel developed with SPARC’s proprietary Nanotecton technology. Paclitaxel is one of the most widely used cytotoxic agents and is approved for the treatment of Breast cancer, Ovarian cancer, Non-Small Cell Lung cancer and Pancreatic cancer.

Sun Pharma Advanced Research Company (SPARC) is a clinical stage bio-pharmaceutical company which was formed in 2007 through a demerger from Sun Pharma.

The stock of SPARC in Monday's trading session opened at Rs. 114.25 per share and touched intra day high of Rs. 120.30. At 11:23 hours, the stock was trading at Rs. 116.70, up by 0.56 per cent.

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