RANBAXY APPROVED TO MARKET FOUR MORE DOSAGES OF SIMVASTATIN

Ranbaxy Laboratories announced it has received approval from the FDA to manufacture and market generic simvastatin tablets, 5, 10, 20 and 40 mg. The FDA's Office of Generic Drugs has determined Ranbaxy's product to be bioequivalent, therefore, therapeutically equivalent to the listed drug, Merck's Zocor. Total annualized market sales for Simvastatin were $4.8 billion, according to Ranbaxy.

Simvastatin is indicated in the treatment of patients diagnosed with or at high risk of developing heart disease, patients with hypercholesterolemia requiring modifications of lipid profiles and adolescent patients with Heterozygous Familial Hypercholesterolemia.

Ranbaxy has exclusively marketed 80-mg tablets of simvastatin since the patent expired in June. Teva Pharmaceutical Industries originally received approval for generic Zocor in the 5, 10, 20 and 40 mg strengths. As the first company to file an abbreviated new drug application containing a paragraph IV certification for these dosage strengths, Teva had 180 days of market exclusivity, which expired last week.