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Lupin gets USFDA nod to market generic Penicillamine tablets

IBEF:  December 02, 2020

On Tuesday, drug firm Lupin said it had obtained clearance from the US health regulator to sell on the American market its generic penicillamine tablets used for the treatment of Wilson's disease and cystinuria.

Lupin said in a regulatory filing that the company has obtained approval from the United States Food and Drug Administration (USFDA) for the marketing of its USP 250 mg penicillamine tablets.

The product is a generic version of the Depen tablets from Mylan Specialty LP with the same power, it added.

Lupin said that the tablets will be manufactured at Lupin's Nagpur facility and are expected to be launched soon.

Penicillamine tablets USP had an overall annual selling of around USD 4 million in the US, Lupin said, according to the IQVIA MAT September 2020 results.

Penicillamine Tablets USP, 250 mg, are prescribed for the treatment of Cystinuria, Wilson's disease, and in patients with serious active rheumatoid arthritis who have not adapted to an effective traditional therapy trial, it added.

On Tuesday, Lupin's shares closed at Rs. 909.75 (US$ 12.28) per scrip on the BSE, up 2.01% from its previous close.

Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.