RANBAXY GAINS TENTATIVE APPROVAL TO MARKET ADDITIONAL
STRENGTHS OF GLIMEPIRIDE TABLETS
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
Glimepiride Tablets, 3 mg and 6 mg. Total annual market
sales for Amaryl® Tablets were $336.6 million (+22.4%)
(IMS – MAT: March 2005).
Glimepiride is indicated as an adjunct to diet and exercise
to lower the blood glucose in patients with noninsulin-dependent
(Type II) diabetes mellitus (NIDDM) whose hyperglycemia
cannot be controlled by diet and exercise alone. Glimepiride
may be used concomitantly with metformin when diet,
exercise, and Glimepiride or metformin alone do not
result in adequate glycemic control. Glimepiride is
also indicated for use in combination with insulin to
lower blood glucose in patients whose hyperglycemia
cannot be controlled by diet and exercise in conjunction
with an oral hypoglycemic agent. Combined use of Glimepiride
and insulin may increase the potential for hypoglycemia.
“We are pleased to receive this tentative approval
for Glimepiride Tablets. This product represents an
interesting opportunity for Ranbaxy in which we will
offer six strengths of this oral hypoglycemic agent
to support dosing flexibility that will be of benefit
to both prescribers and patients. Glimepiride Tablets,
1, 2 and 4 mg strengths are available through the innovator
company. RPI will offer these tablet strengths, as well
as 3, 6, and 8 mg that are additional strengths developed
through Ranbaxy’s R&D organization. Product
will be launched following final approval from the FDA
on October 6, 2005," according to Jim Meehan, Vice
President of Sales and Marketing 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, manufactures and markets brand and generic
pharmaceuticals and Active Pharmaceutical Ingredients.
Ranbaxy's continued focus on R&D has resulted in
several approvals in developed markets and significant
progress in New Drug Discovery Research. Ranbaxy's foray
into Novel Drug Delivery Systems has led to proprietary
"platform technologies" resulting in a number
of products under development. The Company is selling
its products in over 100 countries and has an expanding
international portfolio of affiliates, joint ventures
and alliances, ground operations in 44 countries and
manufacturing operations in 7 countries.
*Amaryl® is a registered trademark of Aventis
Pharmaceuticals, Inc.
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