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.
LEO Pharma advances delgocitinib cream into phase 3 trial for lichen sclerosus
HistoIndex partners Houston Research Institute
Formosa Pharmaceuticals licenses APP13007 ophthalmic therapy to Samil for South Korea
Bambusa Therapeutics reports first patient dosed in proof-of-concept COPD trial
Elanco Animal Health's Befrena (tirnovetmab) receives USDA approval for canine dermatitis
Sanofi and Regeneron's Dupixent gains Japan approval for paediatric asthma patients aged 6 to 11
Aqualung Therapeutics' Phase 2a lung fibrosis study approved by US FDA
Alvotech launches first-in-market golimumab biosimilar in Europe
Physiomics secures follow-on UK contract for Phase 2 study support
RedHill Biopharma reports positive opaganib data in venetoclax-resistant CLL
InduPro secures strategic investment and collaboration with Sanofi to advance autoimmune therapy
Innovent Biologics reports first participant dosed in Phase 1 trial of IBI3011