FDA APPROVES GENERIC ZOCOR UPON END OF EXCLUSIVITY PERIOD

The FDA approved abbreviated new drug applications filed by six generic drugmakers, allowing them to market generic versions of Merck's cholesterol treatment drug Zocor.

Drug companies that received FDA approval were Dr. Reddy's Pharmaceuticals, Sandoz, Cobalt Pharmaceuticals, Aurobindo Pharma, Zydus Pharmaceuticals and Perrigo.

The Dec. 20 approvals came a day after expiration of the 180-day marketing exclusivity period won by first-filers Ranbaxy Laboratories and Teva Pharmaceutical June 23 to market generic simvastatin, the active ingredient in Zocor, in certain doses. Ranbaxy received approval to market 80-mg tablets, while Teva Pharmaceutical, through its subsidiary Ivax, obtained approval to market 5-, 10-, 20- and 40-mg tablets.

Ranbaxy and Teva immediately launched sales of generic simvastatin after successfully fending off a legal action brought by the FDA that sought to block the guaranteed 180-day marketing exclusivity period for their approved drugs. That period ended Dec. 19.

Zocor generated nearly $4.5 billion in sales for Merck last year, according to industry figures.