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FDA approves Par's diabetes drug


WOODCLIFF LAKE, N.J. A generic drug maker has received final approval for a Type 2 diabetes treatment.

Par Pharmaceutical announced that the Food and Drug Administration approved its ANDA for nateglinide tablets. Nateglinide is a generic version of Novartis' Starlix. Nateglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus.

Par will begin shipping the 60-mg and 120-mg strengths of nateglinide to the trade immediately.

Annual U.S. sales of Starlix are approximately $124 million, according to IMS Health data.

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