FDA issues final guidance on generic drug appearance
Sandoz launches Glatopa as first U.S. Copaxone generic
HOLZKIRCHEN, Germany — Sandoz has launched Glatopa, the first U.S. generic of Teva’s Copaxone (glatiramer acetate injection, 20-mg/ml ), a once-daily treatment for multiple sclerosis. The drug was developed in collaboration with Momenta and approved by the FDA in April.
“Sandoz, together with Momenta, is proud to announce the US market launch of a fully substitutable generic version of this important therapy, following FDA approval,” Sandoz U.S. President Peter Goldschmidt said.
The company is also introducing a patient support service that includes financial assistance for qualifying patients, injection training, and access to nurses for non-clinical questions 24 hours a day.
FDA approves new indication for Eisai’s Fycompa
WOODCLIFF LAKE, N.J. — Eisai announced Monday that the Food and Drug Administration had given the company approval for a new indication for its seizure treatment Fycompa. The medication has been approved as an adjunctive therapy in treating primary generalized tonic-clonic seizures (PGTC).
The approval of FYCOMPA to treat patients age 12 and older with PGTC seizures represents an important next step toward expanding treatment options for patients whose PGTC seizures are not adequately controlled with their current medication,” Lynn Kramer Eisai’s chief clinical officer and president of Eisai’s Neuroscience and General Marketing Unit, said. “Eisai is committed to advancing epilepsy care and making contributions to help address the diversified needs of epilepsy patients and their families as part of its corporate humane healthcare mission.”
Fycompa is available in 2-, 4-, 6-, 8-, 10- and 12-mg dosage strengths, and patients who are eligible can register at Fycompa.com for a Fycompa savings card.