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BALTIMORE — Lupin Pharmaceuticals Inc., the U.S. arm of India-based Lupin Ltd., has launched the first product from its Gavis pipeline, zolpidem sublingual tablets 1.75 mg and 3.5 mg, an insomnia drug.
Lupin said its product is a generic version of Intermezzo sublingual tablets (1.75 mg and 3.5 mg) from Purdue Pharma.
The Lupin generic received final approval from the Food & Drug Administration as well as final clearance from the Federal Trade Commission, with 180 days of exclusivity, the company said.
Used as needed, zolpidem sublingual tablets are indicated for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Intermezzo totaled U.S. sales of $9.46 million in the 12 months through December 2015, according to IMS Health data cited by Lupin.
