Ranbaxy will benefit from the 180 day shared exclusivity on the product
PRINCETON, N.J., Aug. 30 /PRNewswire/ -- 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
|SOURCE Ranbaxy Pharmaceuticals Inc.|
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