Ranbaxy receives approval to market Sumatriptan Succinate tablets

Aug 12 2009

Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received final approval from the U.S. Food and Drug Administration to manufacture and market Sumatriptan Succinate Tablets, 25 mg (base), and 50 mg (base).

The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Imitrex(R) by GlaxoSmithKline. Total annual market sales for Sumatriptan Succinate 25 mg and 50 mg tablets were $379 million (IMS - MAT: June 2009) which is indicated for the acute treatment of migraine attacks with or without aura in adults.

"We are pleased to receive this final approval for Sumatriptan Succinate Tablets 25 mg and 50 mg in addition to the 100 mg that was previously approved. This FDA approval represents the sixth such authorization to commercialize product to be granted by the agency so far in 2009. This product will be launched immediately to all classes of trade and further expands our product portfolio of affordable generic product formulations, that will be of benefit to patients, healthcare professionals and the U.S. healthcare system," according to Bill Winter, Vice President, Trade Sales, North America.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. RPI is engaged in the sale and distribution of 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 range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies", resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries. Ranbaxy is a subsidiary of Daiichi Sankyo Company, Ltd.

*Imitrex(R) is a registered trademark of GlaxoSmithKline