USFDA nod for Granules product

The USFDA has approved Granules Pharmaceuticals Inc.’s abbreviated new drug application (ANDA) for Penicillamine Capsules USP, 250 mg. The approved product is a bioequivalent to the reference listed drug Cuprimine of Bausch Health Americas Inc. It will be manufactured at Granules facility in Chantilly, Virginia and expected to be unveiled launched shortly, parent company Granules India said on Thursday.

Penicillamine capsules are indicated in the treatment of Wilson’s disease, cystinuria and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy, a release said. Penicillamine capsules had U.S. sales of approximately $67 million for the most recent twelve months ending in October 2020, the company said citing IQVIA Health.

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