EAST HANOVER, N.J. — Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Gilenya (fingolimod) for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis, making it the first disease-modifying therapy indicated for these patients. This approval expands the age range
HERTFORDSHIRE, England and PITTSBURGH and NESS ZIONA, Israel — Mylan N.V. and Mapi Pharma Ltd. announced that the two companies will team on the development and commercialization of GA Depot, a long-acting Glatiramer Acetate product. Mylan is acquiring global marketing rights to the product. GA Depot is a proposed once-monthly injection for the treatment of
NEW YORK — Pfizer Inc. has entered into an agreement with Synthon to acquire the exclusive U.S. commercialization rights for glatiramer acetate, a potential generic version of Teva Pharmaceuticals’ Copaxone for the treatment of relapsing remitting multiple sclerosis (RRMS). Pfizer said Monday that under the agreement, it will have exclusive rights to commercialize both dosage
HOLZKIRCHEN, Germany — Sandoz has begun shipment of Glatopa, a one-time daily treatment for multiple sclerosis (MS), in the United States. The Novartis subsidiary said Thursday that the product (glatiramer acetate injection, 20 mg/ml) is the first generic version of Copaxone 20 mg, from Teva Pharmaceuticals. Developed in collaboration with Momenta and made in the
HOLZKIRCHEN, Germany — Sandoz has received Food and Drug Administration approval for Glatopa, a treatment for multiple sclerosis (MS). The Novartis subsidiary said Thursday that its product is the first generic version of Teva’s Copaxone (glatiramer acetate injection) 20 mg/ml once-daily MS therapy. Glatopa, developed in collaboration with Momenta and made entirely in the United
