Thursday, Par Pharmaceutical Companies, Inc. (PRX) said it received a final approval from the U.S. Food and Drug Administration to market nateglinide tablets, a drug indicated in the treatment of type II diabetes.
Nateglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type II diabetes mellitus. Nateglinide is a generic version of Novartis' Starlix. It is estimated that Starlix has annual U.S. sales of approximately $124 million, according to IMS Health data.
Par will begin shipping the 60mg and 120mg strengths of nateglinide immediately.
Nateglinide lowers blood glucose by stimulating the release of insulin from the pancreas. It achieves this by closing ATP-dependent potassium channels in the membrane of the beta cells. This depolarizes the beta cells and causes voltage-gated calcium channels to open. The resulting calcium influx induces fusion of insulin-containing vesicles with the cell membrane, and insulin secretion occurs.
Nateglinide tablets are contraindicated in patients with known hypersensitivity to the drug or its inactive ingredients.
PRX is currently trading at $21.58, up $0.39 or 1.84%, on a volume of 0.737 million shares on the NYSE.
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