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news.Mylan Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) to launch Eprosartan Mesylate Tablets, 400 mg (base) and 600 mg (base).
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Eprosartan Mesylate is the generic version of Abbott Laboratories’ Teveten Tablets, indicated for the treatment of hypertension.
The company has been awarded 180 days of marketing exclusivity and will begin shipping the drug immediately.
Eprosartan Mesylate Tablets, 400 mg (base) and 600 mg (base) generated sales of approximately $4.9m for the 12 months ending 30 September in the US, IMS Health’s data said.
In addition, Mylan is said to have 170 ANDAs pending FDA approval representing $98.4bn in annual sales.