Updated on 17 April 2015
Sandoz gets FDA nod for MS generic drug
Singapore: Sandoz, a Novartis company, has recieved USFDA approval of Glatopa, a first generic version of Teva's Copaxone (glatiramer acetate injection) for multiple sclerosis therapy.
"Sandoz is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy," said Mr Peter Goldschmidt, president, 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.