India’s drug control body has withdrawn a decision to block the sale of Natco Pharma’s breast cancer drug Albupax, after the company successfully appealed the result of a failed test.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