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, N.J. -- Ranbaxy Laboratories Limited 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.