The United States Food and Drug Administration (FDA) has granted final approval to India-based Cipla Limited (BSE: 500087)(NSE: CIPLA EQ) for its abbreviated new drug application (ANDA) for Dimethyl Fumarate DR Capsules 120mg, 240mg and 120mg/240mg Starter Pak, it was reported on Monday.
The product is an AB-rated generic therapeutic equivalent version of Biogen IDEC's Tecfidera.
The product is intended to be used for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is available for shipping immediately.
Biocon's first US manufacturing facility inaugurated in Cranbury, New Jersey
Amneal's risperidone extended-release injectable suspension approved by US FDA
First FDA acceptance to waive clinical efficacy studies for monoclonal antibody biosimilars
Coya Therapeutics wins FDA clearance to advance COYA 302 into Phase 2 ALS trial
Viatris' generic iron sucrose injection gains US FDA approval
Newbury Pharmaceuticals gains Finnish approval for generic melatonin
CivicaScript to distribute biosimilar for chronic inflammatory conditions
Mallinckrodt and Endo complete merger
Zenara Pharma's Sertraline Hydrochloride Capsules generic receives US FDA approval
Mallinckrodt receives Irish High Court ruling to combine with Endo Inc
Accord Healthcare introduces Dehydrated Alcohol Injection for cardiovascular indications
CivicaScript introduces low-cost multiple sclerosis treatment
Breckenridge Pharmaceutical's generic for Ablysinol granted final FDA approval
Glenmark Therapeutics launches Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC)