Amerigen Pharmaceuticals Limited wins US FDA approval for Penicillamine Capsules USP in 250 mg
9 May 2019 -

Generic pharmaceutical business Amerigen Pharmaceuticals Limited reported on Wednesday the receipt of final approval from the US Food and Drug Administration for the Abbreviated New Drug Application (ANDA) for Penicillamine Capsules USP in 250 mg.

According to the company, Penicillamine Capsules USP are indicated in the treatment of Wilson's disease, cystinuria as well as in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy.

This is the first ANDA to be approved as a generic equivalent to Bausch Heath's Cuprimine, Amerigen said.

In the US, the Penicillamine Capsules USP in 250 mg has already been launched by the company's affiliate, Amerigen Pharmaceuticals Inc.