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FDA Approves Impax’s Generic Diabetes Treatment

By Pharmaceutical Processing | May 19, 2009

HAYWARD, Calif. (AP) — Impax Laboratories Inc. said Tuesday federal regulators have approved the company’s application to make generic versions of the diabetes treatment Precose. The FDA approved an abbreviated new drug application for 25-, 50- and 100-milligram strengths of the tablets. Impax expects to launch all strengths in the fourth quarter. Impax said in a statement U.S. generic and branded sales of the drug, also known as acarbose, in those three strengths were about $32 million for the 12 months that ended in March. Bayer HealthCare Pharmaceuticals makes Precose, which manages Type 2 diabetes mellitus.

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