Panacea Biotec gets acceptance for ANDA for Paclitaxel Protein Bound Particles for filing

By USFDA

Panacea Biotec announced that its abbreviated new drug application (ANDA) submitted under section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) for Paclitaxel Protein Bound Particles for injectable Suspension, 100mg/vial has been accepted for filing by the U.S. Food and Drug Administration (FDA).

This product is the generic version of Abraxane, marketed for the treatment of Metastatic Breast Cancer, Non Small Cell Lung Cancer and Adenocarcinoma of the Pancreas in the US market.

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