Ranbaxy gets final ok to market Simvastatin
Ranbaxy Laboratories Limited (RLL), announced that the company has received approval from the US Food and Drug Administration to manufacture and market Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg and 40 mg in the US.
The FDA’s Office of Generic Drugs has determined Ranbaxy’s Simvastatin Tablets USP, to be bioequivalent, therefore, therapeutically equivalent to the listed drug Zocor Tablets. Total annualised 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 (IMS – MAT: September 2006).
“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 US healthcare system,” according to Jim Meehan, Vice-President of Sales and Marketing for RPI, USA. Simvastatin tablets are indicated in the treatment of patients with coronary heart disease (CHD) or at high risk of CHD.