FDA Approves First Generic Version of Zocor

June 29, 2006
Patricia Van Arnum

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The US Food and Drug Administration (Rockville, MD) approved the first generic versions of "Zocor" (simvastatin), the anticholesterol drug by Merck & Co., Inc. (Whitehouse Station, NJ).

The US Food and Drug Administration (Rockville, MD, www.fda.gov) approvedthe first generic version of "Zocor" (simvastatin), the anticholesteroldrug by Merck & Co., Inc. (Whitehouse Station, NJ, www.merck.com).  

Simvastatin tablets (5, 10, 20, and 40 mg) are manufactured by IvaxPharmaceuticals, Inc., a wholly owned subsidiary of Teva PharmaceuticalIndustries Limited (Petach Tikva, Israel, www.tevapharm.com).Simvastatin tablets (80 mg) are manufactured by RanbaxyPharmaceuticals, Inc, the US arm of Ranbaxy Laboratories Limited.(Gurgaon, Haryana, India, www.ranbaxy.com).

Merck's US marketing exclusivity for Zocor expired in June 2006. Zocorposted 2005 sales of $4.4 billion, a 16% decline from 2004, as salesoutside of the US were affected by the availability of genericsimvastatin.