Lupin gets USFDA nod to market generic Penicillamine tablets

The company has received approval to market its Penicillamine tablets USP, 250 mg, from the United States Food and Drug Administration (USFDA), Lupin said in a regulatory filing. The product is a generic version of Mylan Specialty LP's Depen tablets in the same strength, it added.

Drug firm Lupin on Tuesday said it has received approval from the US health regulator to market its generic Penicillamine tablets used for treatment of Wilson's disease and Cystinuria in the American market. The company has received approval to market its Penicillamine tablets USP, 250 mg, from the United States Food and Drug Administration (USFDA), Lupin said in a regulatory filing.

The product is a generic version of Mylan Specialty LP's Depen tablets in the same strength, it added. The tablets would be manufactured at Lupin's Nagpur facility and is expected to be launched shortly, Lupin said.

According to the IQVIA MAT September 2020 data, Penicillamine tablets USP had a total annual sale of around USD 4 million in the US, Lupin said. 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, it added.

Shares of Lupin on Tuesday closed at Rs 909.75 per scrip on the BSE, up 2.01 per cent from its previous close.