Food and Drug Administration (FDA) clearance of Pfizer Inc.’s generic version of the top-selling multiple sclerosis (MS) drug Copaxone is expected the first quarter of 2017, but an agency warning letter disclosed last week regarding a May 2016 inspection could delay that approval. Copaxone is manufactured by Teva Pharmaceutical Industries Ltd., and is one of the world’s best-selling drugs, generating sales of $3.5 billion last year in the U.S. alone. Pfizer’s generic, called Glatopa, is manufactured partnership with Sandoz Inc. and Momenta Pharmaceuticals Inc. Glatopa has been available in a 20-milligram version since 2015, but the 40-milligram version makes up about 84 percent ... Read More
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