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FDA grants final approval for Acarbose tablets ANDA: Mylan Pharma

The US Food and Drug Administration (FDA)has granted final approval for Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Acarbose tablets, 25mg, 50mg and 100mg.

Mylan Pharmaceuticals, a subsidiary of Mylan Inc, has claimed that its Acarbose tablets is the generic version of Bayer’s Precose tablets, a treatment to be used with diet and exercise to improve glycemic control in adults with type 2 diabetes.

Acarbose is an anti-diabetic drug used to treat type 2 diabetes mellitus and, in some countries, prediabetes.

It is sold in Europe under the brand name Glucobay (Bayer), in North America as Precose (Bayer Pharmaceuticals), and in Canada as Prandase (Bayer).