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.
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial