Lupin gets USFDA approval for Penicillamine tablets

It is indicated in the treatment of Wilson’s disease, Cystinuria, and in patients with severe, active rheumatoid arthritis

Pharma major Lupin Limited has received approval from the United States Food and Drug Administration (FDA) to market for penicillamine tablets USP, 250 mg, a generic equivalent of Depen tablets, 250 mg, of Mylan Specialty, L.P.

The product would be manufactured at Lupin’s Nagpur facility and is expected to be launched shortly.

Penicillamine tablets USP, 250 mg, 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.

Penicillamine tablets USP had an annual sales of approximately US$4 million in the US, according to IQVIA MAT September 2020.

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