FDA Grants Final Approval to Ivax and Ranbaxy for Generic Zocor

The FDA today granted final approval to Ivax and Ranbaxy to market generic versions of Zocor (simvastatin).  Additionally, it appears the FDA has granted generic marketing exclusivity to Ivax and Ranbaxy for the next 180 days.

The FDA approval comes despite a last-ditch effort by Novartis subsidiary Sandoz to prevent the FDA from granting final approval and marketing exclusivity to Ivax and Ranbaxy.  Earlier today, the U.S. District Court for the District of Columbia refused to grant Sandoz's request for a temporary restraining order against the FDA.

In a press release announcing the approval, the FDA stated, "This approval is another example of our agency's efforts to increase access to safe and effective generic alternatives as soon as the law permits."  The FDA has appealed a district court ruling that required the FDA to grant final approval to Ivax and Ranbaxy today, the day Merck's final patent on Zocor expired.  That appeal is still pending before the D.C. Circuit.

RELATED READING:

• 23 June 06 MarketWatch.com story
• 23 June 06 Reuters article

UPDATES:

• 24 June 06 Bloomberg story:  Insurance Companies Push Generic Zocor
• Dr. Reddy's launches authorized generic Zocor