Vinita Gupta, president and managing director of Lupin, said: “We are delighted to receive final FDA approval for simvastatin tablets. The addition of generic Zocor complements Lupin’s commitment to bringing high-quality, low cost drug alternatives to the American public.”
Zocor, Merck’s statin for modifying cholesterol, achieved worldwide sales of $2.8 billion, a 36% decrease compared to the full year of 2005. Merck’s US marketing exclusivity for Zocor expired on June 23, 2006.
With this approval, Mumbai-based Lupin now has 21 abbreviated new drug applications approved by the US FDA.