Watson’s pravastatin sodium product is the authorized generic version of Bristol-Myers Squibb’s Pravachol and is indicated along with diet to reduce the risk of both first heart attack in patients with elevated cholesterol and recurrent heart attack or a stroke in patients with heart disease, when diet and exercise are not enough.
In 2005, Pravachol was the 22nd highest-selling brand-name drug in the US, with sales totaling $1.3 billion. Bristol-Myers Squibb’s patent for the drug expired on April 20, 2006.
Watson’s announcement came just a day after the FDA approved the first generic version of Pravachol, which will be manufactured and marketed by Israeli generics heavyweight Teva Pharmaceuticals.
In addition to announcing the Teva approval, the FDA also reported that the Office of Generic Drugs (OGD) is continuing with work to review and take action on generic drug applications as quickly as possibly.
There are several process improvements underway at the FDA to facilitate in the review of generic drug applications. Among other things, the OGD is considering several simple, yet innovative new policies that could lead to the overall reduction of review time. These include new review formats that allow for overall risk assessments for individual applications in order to dictate the level of OGD review need for subsequent product changes.