HOLZKIRCHEN, Germany - Sandoz, a Novartis company, on Thursday announced the U.S. approval of Glatopa, 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," stated 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."
MS is a debilitating disease affecting about half a million individuals in the U.S. alone; only half of those diagnosed are currently treated.
Glatopa, developed in collaboration with Momenta and produced entirely in the U.S., 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 features consistent with MS.