Par Pharmaceutical has received final approval from the FDA for its Abbreviated New Drug Application for nateglinide tablets. Nateglinide is a generic version of Novartis’ Starlix.
The company said that the annual US sales of Starlix is approximately $124m.
Reportedly, Par Pharmaceutical will begin shipping the 60mg and 120mg strengths of nateglinide to the trade immediately.
The company said that Nateglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type II diabetes mellitus.
The company claims that the Nateglinide tablets are contraindicated in patients with a known hypersensitivity to the drug or its inactive ingredients, Type I diabetes and diabetic ketoacodosis
Par Pharmaceutical develops, manufactures and markets generic drugs and branded pharmaceuticals for specialty markets.