Ranbaxy Granted Final FDA Approval To Market Simavastatin 5, 10, 20 And 40 Mg Tablets
02 January, 2007
Ranbaxy Laboratories Limited, announced today that the Company has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg and 40 mg in the U.S. The FDA’s Office of Generic Drugs has determined Ranbaxy’s Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg and 40 mg to be bioequivalent, therefore, therapeutically equivalent to the listed drug Zocor Tablets, 5 mg, 10 mg, 20 mg and 40 mg of Merck Research Laboratories. Total annualized market sales for Simvastatin were $4.8 billion, of which $4.2 billion were for the 5 mg, 10 mg, 20 mg and 40 mg tablets.
Simvastatin tablets are indicated in the treatment of patients with coronary heart disease (CHD) or at high risk of CHD, reductions in risk of CHD mortality and cardiovascular events, patients with hypercholesterolemia requiring modifications of lipid profiles and adolescent patients with Heterozygous Familial Hypercholesterolemia (HeFH). A Simvastatin regimen can be started simultaneously with diet.
“Ranbaxy has marketed the 80 mg tablets of Simvastatin on an exclusive basis since the patent expired in June of this year. We are now in a position to expand our product offerings to include the four additional strengths of Simvastatin and can now offer the complete line of marketed strengths for this product to our customers. Simvastatin has assumed a prominent position in the management of patients with hypercholesterolemia, and is now available as an alternative to the brand at an affordable price. This undoubtedly will have a positive economic benefit to patients, as well as to the U.S. healthcare system,” according to Jim Meehan, Vice President of Sales and Marketing for RPI, USA.
