FDA approves generic Zocor

06/26/06 - newratings.com

NEW YORK, June 26 (newratings.com) – The first generic versions of the world's second-biggest cholesterol drug, Zocor (simvastatin), were approved on Friday by the US Food and Drug Administration (FDA).

The FDA said that it has granted exclusive rights for the next six months to Teva Pharmaceutical Industries Ltd (TEVA) and the US unit of India-based Ranbaxy Laboratories Ltd to sell the generic version of Zocor, the patent for which expired on Friday. While Israel-based Teva Pharmaceutical Industries will manufacture the 5mg, 10mg, 20mg and 40mg versions of the drug at Ivax Pharmaceuticals’ plants in Northvale, New Jersey, Ranbaxy Pharmaceuticals will manufacture an 80mg dose, the FDA added. The drug will, however, still require a prescription.

The availability of generic versions of Merck-manufactured Zocor would lead to increased price competition, resulting in the reduction in the cost of the drug for US insurance companies, employers and patients. Merck expects generics of Zocor, its biggest product, to hurt its revenues for the current year by $2 billion.