Generics
US FDA approves Breckenridge Pharmaceutical's Abbreviated New Drug Application for Pomalidomide Capsules
16 November 2020 -

The US Food and Drug Administration (FDA) has approved Breckenridge Pharmaceutical Inc, a subsidiary of Laboratorios Pen, SA, for its Abbreviated New Drug Application (ANDA) for Pomalidomide Capsules (generic for Pomalyst, it was reported on Friday.

Breckenridge Pharmaceutical has collaborated with Natco Pharma Limited for the production and manufacture of this product.

The United States district court litigation with respect to this product have been settled by Celgene, Breckenridge and Natco.

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