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.
ScinoPharm Taiwan secures first US FDA approval for complex multiple sclerosis generic
ScinoPharm Taiwan's Glatiramer Acetate Injection approved by US FDA
International Isotopes Inc to change name to Radnostix Inc
Galmed Pharmaceuticals reports topline results for combination of Aramchol, Stivarga and metformin
Ingenus Pharmaceuticals' generic equivalent to Premarin receives US FDA approval
EirGenix signs second global exclusive licensing deal with Sandoz
Padagis invests USD36m to expand manufacturing in Minneapolis
Newbury Pharmaceuticals gains Danish approval for generic ivermectin cream