Amerigen announced that the company's Abbreviated New Drug Application (ANDA) for Penicillamine Capsules USP 250 mg has received final approval from the U.S. Food and Drug Administration (FDA). This is the first such ANDA to be approved as a generic equivalent to Bausch Heath's Cuprimine®. The finished product is manufactured for Amerigen in the U.S. where it has already been launched by Amerigen's affiliate, Amerigen Pharmaceuticals.
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Penicillamine Capsules USP 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.
"We are delighted to launch this first generic of Penicillamine Capsules. This is Amerigen's ninth U.S. product launch and the fourth time we have brought a first generic to market, with important savings for the American healthcare system," John Lowry, Amerigen's President and CEO, said.