RANBAXY RECEIVES TENTATIVE APPROVAL
TO MANUFACTURE AND MARKET GALANTAMINE TABLETS ON AN EXCLUSIVE
BASIS
Ranbaxy will benefit from the 180 day shared exclusivity
on the product Princeton, New Jersey
– August 30, 2007
Ranbaxy Laboratories Limited (RLL),
announced today that the Company has received tentative
approval from the U.S. Food and Drug Administration
to manufacture and market Galantamine Hydrobromide Tablets,
4mg (base), 8mg (base), and 12mg (base). Galantamine
is indicated for the treatment of mild to moderate dementia
of the Alzheimer’s type. Total annual market sales
for Razadyne were $130.0 million (IMS – MAT: June
2007).
“This tentative approval will
provide Ranbaxy Pharmaceuticals Inc. (RPI) with an opportunity
to market this product and anticipate sharing in the
period of 180 days exclusivity that will be beneficial
to the Company, as well as to the U.S. healthcare system.
We will launch the product upon final approval, which
is anticipated on December 14, 2008. At the time of
launch, product will be available immediately to all
classes of trade“ according to Jim Meehan, Vice
President of Sales and Distribution for RPI.
Ranbaxy Pharmaceuticals Inc. (RPI)
based in Jacksonville, Florida, USA, 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, India's
largest pharmaceutical company, 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.
* Razadyne™ is a registered trademark of Janssen
Pharmaceutica Inc.
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