RANBAXY RECEIVES FINAL APPROVAL
TO MARKET SUMATRIPTAN SUCCINATE TABLETS
Ranbaxy expands product portfolio
by offering all strengths of Sumatriptan tablets
Princeton, NJ – August 11, 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®
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® is a registered trademark
of GlaxoSmithKline
|