Sun's research firm gets DCGI nod for cancer drug

SPARC has licensed Sun Pharmaceutical Industries Limited (SPIL)or its assignee to manufacture, promote and distribute PICN in the Indian market

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Sun Pharma Advanced Research Company (SPARC) gets licensee approval from Drug Controller General of India (DCGI) for Paclitaxel injection concentrate for Nanodispersion (PICN)

Sun Pharma Advanced Research Company (SPARC) announced that its licensee has received an approval from the Drug Controller General of India (DCGI) for Paclitaxel injection concentrate for Nanodispersion (PICN), indicated for the treatment of metastatic breast cancer.

In a clinical study in metastatic breast cancer patients, PICN was found to be equally effective and safe when compared to Abraxane. PICN is approved in India for both 260mg per metre square and 295mg per metre square doses to be administered every 3 weeks.

PICN is a novel formulation of Paclitaxel using SPARC's proprietary Nanotecton platform technology and is a Cremophor and albumin-free formulation. It offers the convenience of a quick and easy one-step dilution and ifusion preparation for healthcare professionals.

PICN can be administered in a short 30 minute infusion and unlike conventional Paclitaxel formulations it does not require premedication with steroids and anti-histamines and does not lead to any significant hypersensitivity reactions in patients.

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