FDA approves generic hypertension pill made by Actavis

Actavis gets 180-day marketing exclusivity for generic telmisartan immediate-release tablets

DUBLIN — The Food and Drug Administration has approved a generic drug for high blood pressure made by Actavis, the company said Friday.

Actavis announced the approval of telmisartan immediate-release tablets in the 20-mg, 40-mg and 80-mg strengths, which it intends to release immediately.

The drug is a generic version of Boehringer Ingelheim's Micardis, which had sales of about $274 million during the 12-month period that ended in September, according to IMS Health. As the first company to successfully apply for approval of a generic version, Actavis has 180 days in which to compete exclusively against Boehringer Ingelheim's product, according to FDA regulations.

 

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