RANBAXY GAINS APPROVAL TO MANUFACTURE
AND MARKET CARVEDILOL TABLETS IN THE US MARKET
BLOCKBUSTER BRAND WILL BE COMMERCIALIZED AS AFFORDABLE
GENERIC Princeton, New Jersey –
September 6, 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 Carvedilol Tablets, 3.125 mg, 6.25 mg, 12.5,
and 25 mg, a beta blocker used to treat heart failure.
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 Coreg® Tablets, 3.125 mg,
6.25 mg, 12.5 mg, and 25 mg, respectively, of GlaxoSmithKline.Total
annual market sales for Carvedilol Tablets were $1.6
billion (IMS – MAT: June 2007).
Carvedilol is indicated for the treatment
of mild-to-severe heart failure of ischemic or cardiomyopathic
origin, usually in addition to diuretics, ACE inhibitor
and digitalis. Carvedilol is also indicated to reduce
cardiovascular mortality in clinically stable patients
who have survived the acute phase of a myocardial infarction,
as well as in the management of essential hypertension,
alone or in combination with other antihypertensive
agents.
“We are pleased to receive this
FDA approval for Carvedilol Tablets that will add depth
and breadth to our product line of medications used
in cardiovascular diseases. This approval further represents
yet another approval in 2007, that expands our product
portfolio of affordable generic alternatives. Carvedilol
will be manufactured at our Ohm Laboratories facility
in New Brunswick, New Jersey and launched in to all
classes of trade early in the fourth quarter of 2007
under the RPI label,” noted Jim Meehan, Vice President
of Sales and Distribution 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.
* Coreg ® is a registered trademark of GlaxoSmithKline.
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