RANBAXY RECEIVES TENTATIVE APPROVAL
FOR VALSARTAN TABLETS
To Benefit from 180 day exclusivity, at launch,
due to its First To File status Princeton,
New Jersey – October 29, 2007
Ranbaxy Pharmaceuticals Inc. (RPI),
a wholly owned subsidiary of Ranbaxy Laboratories Limited
(RLL), announced today that RLL has received tentative
approval from the U.S. Food and Drug Administration
to manufacture and market Valsartan Tablets, 40 mg,
80 mg, 160 mg and 320 mg. Total annual market sales
for Valsartan Tablets were $1.3 billion (IMS –
MAT: June 2007).
Valsartan is indicated for the treatment
of hypertension alone or in combination with other anti-hypertensive
agents. Valsartan is also indicated for the treatment
of heart failure (NYHA class II-IV).
“We are pleased to receive tentative
approval for Valsartan Tablets. We believe, we are first
to file a substantially complete ANDA and will stand
to gain from the 180 day exclusivity available to the
first filer. These product formulations have been developed
organically within Ranbaxy and will further expand our
product portfolio of affordable generic alternatives,”
said 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.
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