India Stays Decision to Block Natco’s Cancer Drug

10 January 2010 (Last Updated January 10th, 2010 18:30)

India's drug control body has withdrawn a decision to block the sale of Natco Pharma's breast cancer drug Albupax, after the company successfully appealed the result of a failed test. The drug, which is a generic version of Abraxis Bioscience's Abraxane and consists of paclitaxel in an al

India's drug control body has withdrawn a decision to block the sale of Natco Pharma's breast cancer drug Albupax, after the company successfully appealed the result of a failed test.

The drug, which is a generic version of Abraxis Bioscience's Abraxane and consists of paclitaxel in an albumin-bound nanoparticle form, originally failed a Drugs Controller General of India (DCGI) test measuring endotoxin levels.

The DCGI has since stayed the suspension of the drug after Natco appealed saying that an appropriate test method to evaluate nanotechnology based protein-bound formulations needed to be developed as the testing method used for such formulations was highly complex and variable.

Natco declared that future plans would soon be announced.