Glenmark receives US FDA approval for hypertension drug nebi
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Glenmark Pharmaceuticals has been granted final approval by the US Food & Drug Administration (FDA) for the hypertension drug nebivolol, for tablets of strengthen 2.5 mg, 5 mg, 10 mg and 20 mg. The approved product is the generic version of Bystolic tablet of Forest Laboratories Llc.

With respect to 180-day generic drug exclusivity, the FDA noted that Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for nebivolol tablets. Therefore, with this approval, the company may be eligible for 180 days of generic drug exclusivity for nebivolol tablets.

Nebivolol, which belongs to a group of drugs called beta-blockers, is used to treat hypertension (high blood pressure). By lowering blood pressure, it lowers the risk of a stroke or heart attack.

http://www.business-standard.com/content/b2b-pharma/glenmark-receives-us-fda-approval-for-hypertension-drug-nebivolol-117052900413_1.html
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