Generics
Breckenridge wins final FDA approval for Pomalidomide Capsules ANDA
16 November 2020 -

Pharmaceuticals company Breckenridge Pharmaceutical Inc reported on Friday the receipt of approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Pomalidomide Capsules.

The company has partnered with Natco Pharma Limited for the development and manufacture of Pomalidomide Capsules (generic, Pomalyst). Pomalidomide is an anti-angiogenic and also acts as an immunomodulator.

Based on the industry sales data, Pomalyst had annual sales of USD957m during the 12 months ending September 2020.

In conjunction, Celgene, Breckenridge and Natco have settled the US district court litigation with respect to Pomalyst.

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