Posted by Michael Wonder on 04 Oct 2017
Mylan announces U.S. FDA approval of first generic for Copaxone 40 mg/mL 3-times-a-week and may be eligible for 180-day exclusivity
3 October 2017 - Mylan also receives U.S. FDA approval of generic for Copaxone 20 mg/mL once daily.
Mylan today announced that the U.S. FDA has approved Mylan's abbreviated new drug applications for glatiramer acetate injection 40 mg/mL for 3-times-a-week injection, an AP-rated, substitutable generic version of Teva's Copaxone 40 mg/mL, and glatiramer acetate injection 20 mg/mL for once daily injection, an AP-rated, substitutable generic version of Teva's Copaxone 20 mg/mL, which are indicated for the treatment of patients with relapsing forms of multiple sclerosis, a chronic inflammatory disease of the central nervous system.
Mylan will begin shipping imminently.
