Ranbaxy Receives Food and Drug Administration Approval To Market Simvastatin 80mg Pills With 180-Day Exclusivity
Ranbaxy Pharmaceuticals Inc.(RPI), a wholly owned subsiwriting of Ranbaxy Laboratories Limited (RLL),announced today that the company has received acceptance from the U.S. Foodand Drug Administration (Food and Drug Administration) to manufacture and market Simvastatin PillsUSP, 80mg with 180-day exclusivity in the U.S. The Food and Drug Administration’s Office of GenericDrugs has determined Ranbaxy’s 80mg Simvastatin Pills USP, to bebioequivalent, therefore, therapeutically equivalent to the listed medicate Zocor(R) Pills, 80mg, of Merck Research Laboratories. Total annualizedmarket sales for Simvastatin were $ 4.6 billion, out of which the 80mgstrength accounted for $513 mil. (IMS - MAT: March 2006).
Simvastatin pills are indicated in the medical care of patients withcoronary heart illness (CHD) or at high risk of CHD, reductions in risk ofCHD mortality and cardiovascular events, patients with hypercholesterolemiarequiring modifications of lipid profiles and adolescent patients withHeterozygous Familial Hypercholesterolemia (HeFH). A Simvastatin regimencan be started simultaneously with diet.
“This marks a significant day in the history of Ranbaxy. We areoffering a generic alternative on an exclusive basis for the second largestpharmaceutical product sold in the U.S. market. Being a fully integrated,research-based pharmaceutical company has allowed us to effectively developthis formulation, successfully challenge the brand and defend attempts tonegate the 180-day exclusivity. We anticipate significant benefits andvalue from our Simvastatin formulation to both patients and prescribers,”said Malvinder Mohan Singh, CEO and Managing Director, RLL.
This Food and Drug Administration acceptance complements Ranbaxy’s strategic direction forgenerics in the U.S. market with respect to this molecule as well as the 57additional ANDA’s that are pending before the Food and Drug Administration, placing Ranbaxy in avery strong, competitive position for the future.
“Ranbaxy is pleased to receive Food and Drug Administration acceptance for this blockbuster medicate .We expect to launch Simvastatin 80mg on an exclusive basis immediately. Webelieve that by offering an affordably priced generic alternative, we willhave a positive impact on the cost of healthcare for patients who have orat high risk of coronary heart illness,” noted Jim Meehan, Vice Presidentof Sales and Marketing for RPI.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, USA,is wholly owned subsiwriting of Ranbaxy Laboratories Limited (RLL), India’slargest pharmaceutical company. RPI is engaged in the sale and distributionof generic and branded prescription products in the U.S. healthcare system.
Ranbaxy Laboratories Limited, headquartered in India, is an integrated,research based, international pharmaceutical company producing a wide rangeof quality, affordable generic medicines, trusted by healthcareprofessionals and patients across geographies. Ranbaxy’s continued focus onR&D has resulted in several acceptance s in developed markets and significantprogress in New Drug Discovery Research. The Company’s foray into NovelDrug Delivery Systems has led to proprietary “platform technologies,”resulting in a number of products under development. The Company is servingits customers in over 125 countries and has an expanding internationalportfolio of affiliates, joint ventures and alliances, ground operations in49 countries and manufacturing operations in 8 countries.
Ranbaxy Pharmaceuticals Inc.
http://www.ranbaxy.com/