RANBAXY RECEIVES
APPROVAL TO MANUFACTURE AND MARKET HYDROCODONE BITARTRATE
AND ACETAMINOPHEN TABLETS USP
Princeton, NJ – August 20, 2007
Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary
of Ranbaxy Laboratories Limited (RLL), announced today
that RLL has received approval from the U.S. Food and
Drug Administration to manufacture and market Hydrocodone
Bitartrate and Acetaminophen Tablets USP, 7.5 mg/750
mg, 10 mg/500 mg, 5 mg/500 mg, and 10 mg/325 mg strengths.
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 drugs as follows: 10 mg/325 mg Norco
Tablets of Watson Pharmaceuticals Inc., 5 mg/500 mg
Vicodin Tablets, and 7.5 mg/750 mg Vicodin ES Tablets
both of Abbott Laboratories, and 10 mg/500 mg Lortab
Tablets of UCB Inc. Total annual market sales for Hydrocodone
Bitartrate and Acetaminophen Tablets were $390.6 million
(IMS – MAT: June 2007).
“Hydrocodone Bitartrate and Acetaminophen
Tablets are indicated for the relief of moderate to
moderately severe pain and Ranbaxy is pleased to receive
final FDA approval for multiple strengths of this product.
These approvals further expand our product portfolio
of affordable generic alternatives and will be launched
in a November 2007 time period to all classes of trade,”
according to Jim Meehan, Vice President of Sales and
Marketing for RPI.
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.
*Vicodin® ES Tablets is a
registered trademark of Abbott Laboratories
*Norco® Tablets is a registered trademark of Watson
Pharmaceuticals Inc.
*Lortab® Tablets is a registered trademark of UCB
Inc.
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