Sandoz Receives FDA Approval for Glatopa as the First Generic Competitor to MS Therapy Copaxone 20 mg

Sandoz, a Novartis company, has announced the US approval of GlatopaTM, the first generic version of Teva's Copaxone (glatiramer acetate injection) 20 mg/mL one-time-daily multiple sclerosis therapy. 

"Sandoz, together with Momenta, is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy," said Peter Goldschmidt, President of Sandoz US. "The approval of Glatopa reinforces Sandoz leadership in complex, differentiated generic products and further demonstrates our commitment to offer patients and payors a full range of therapeutic options."

Glatopa, developed in collaboration with Momenta and produced entirely in the US, is indicated for the treatment of patients with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with MS.

Fighting MS, together with other CNS disorders, is central to the Novartis mission, and Sandoz's Glatopa joins a broad MS portfolio including two approved therapies and one late-stage development compound.