FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Sandoz’s 40mg Copaxone Generic Gets FDA Approval After Delay

Feb. 16, 2018

The FDA approved a larger dosage of Glatopa, Sandoz’s generic version of Teva’s multiple sclerosis drug Copaxone.

Glatopa is a three-times-a-week therapy developed in collaboration with Momenta Pharmaceuticals. The newly-approved 40mg dosage is expected to be launched no earlier than 2019.

Glatopa has been available in 20mg dosage since 2015. Approval of its double dosage was put on hold last year due to contamination issues.

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