News - Hypertension Week of July 13, 2003/ Vol. 2 No. 28

FDA Gives Tentative Approval to Generic Fosinopril Sodium for Hypertension

For the first time, the U.S. Food and Drug Administration (FDA) has granted tentative approval for a generic version of the drug fosinopril sodium to treat hypertension.

The agency recently tentatively approved Teva Pharmaceutical Industries' new drug application for fosinopril sodium tablets in 10mg, 20mg and 40mg strengths.

Fosinopril sodium tablets are the AB-rated generic equivalent of Bristol-Myers Squibb's Monopril® tablets, which are indicated for the treatment of hypertension and the management of congestive heart failure. Annual sales are approximately $269 million.

Teva is currently wrangling with with Bristol-Myers Squibb in court over this product. Both companies are awaiting a decision on the matter in federal district court.

Other sources: Teva Pharmaceuticals