US pharmaceutical company Apotex Corp announced on Tuesday the launch of nilotinib capsules, a generic version of Tasigna, in the United States, with 180 days of exclusivity.
Nilotinib is a kinase inhibitor indicated to treat certain types of leukaemia, including newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) in chronic phase in adults and children aged 1 year and older. It is also indicated for adults and paediatric patients with chronic or accelerated phase Ph+ CML with resistance or intolerance to prior therapy, demonstrating higher efficacy compared with other available treatments.
"The launch of nilotinib highlights our commitment to providing affordable, high-quality, critical medications to patients in need," said Christine Baeder, president, Apotex USA. "By offering the first generic version of this important leukaemia treatment, we improve access and outcomes for both adult and paediatric patients facing this serious disease."
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
Zenara Pharma's Sertraline Hydrochloride Capsules generic receives US FDA approval
EQT agrees to acquire majority stake in Adalvo
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)
AB Science secures Canadian patent for AB8939, completing global IP coverage for AML treatment