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news.Momenta Pharmaceuticals has announced that the FDA has accepted to review the abbreviated new drug application for a generic version of Copaxone, submitted by Sandoz, Momenta's development and commercialization partner for this product.
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Copaxone is indicated for the reduction of the frequency of relapses in patients with relapsing-remitting multiple sclerosis.
Craig Wheeler, president and CEO of Momenta, said: “Advancing the M356 program for the development of a generic version of Copaxone is one of Momenta’s top priorities, and we are pleased that the abbreviated new drug application (ANDA) has been accepted for review.”