Lupin Pharmaceuticals Inc, the US-based subsidiary of Lupin Limited, has launched the first product from its GAVIS pipeline, zolpidem sublingual tablets (1.75 mg & 3.5 mg), having received final approval from the US Food & Drug Administration (FDA) earlier, as well as final clearance from the FTC with 180 days of exclusivity.
Zolpidem sublingual tablet is a generic version of Purdue Pharma’s Intermezzo, which had recorded sales of $ 9.46 million in 2015, as per IMS data. Zolpidem sublingual tablet is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.
