Research & Development
Amerigen wins US FDA approval for generic Penicillamine in 250 mg capsules
10 May 2019 -

Pharmaceutical group Amerigen Pharmaceuticals Limited reported on Friday the receipt of the US Food and Drug Administration's final approval for its Abbreviated New Drug Application (ANDA) for Penicillamine Capsules USP in 250 mg in the treatment of Wilson's disease, cystinuria and severe, active rheumatoid arthritis.

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

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

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.

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