FDA Accepts Mylan’s ANDA Filing For Generic Copaxone

The FDA has accepted for filing Mylan’s abbreviated new drug application (ANDA) for Glatiramer Acetate Injection (20mg/mL), a generic version of Teva’s Copaxone. The product is indicated for the treatment of multiple sclerosis.

Mylan has entered into a license and supply agreement with NATCO Pharma, which granted Mylan exclusive distribution rights for Glatiramer Acetate pre-filled syringes in the US and all major markets in Europe, Australia, New Zealand, Japan and Canada. Reportedly, the agreement also includes an option to potentially expand into additional territories.

Mylan operates as an active pharmaceutical ingredient manufacturer, and runs a specialty business focused on respiratory and allergy therapies. The company provides products to customers in more than 140 countries and territories.