Ranbaxy Receives USFDA Approval to Market Clorazepate Dipotassium Tablets USP

Main Category: Anxiety / Stress
Article Date: 30 Sep 2004 - 18:00 PDT

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Ranbaxy Laboratories Limited (Ranbaxy) announced today that the Company has received approval from the U.S. Food and Drug Administration to manufacture and market Clorazepate Dipotassium Tablets USP, 3.75 mg, 7.5 mg, and 15 mg. 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, Tranxene® Tablets, 3.75 mg, 7.5 mg, and 15 mg, respectively, of Ovation Pharmaceuticals, Inc.. Total market sales for Clorazepate Dipotassium Tablets are $21.8 million (IMS - MAT: June 2004).

Tranxene® is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Tranxene® tablets are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of Tranxene® tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefulness of the drug for the individual patient. Tranxene® tablets are indicated for the symptomatic relief of acute alcohol withdrawal.

"We look forward to introducing this product to the market within the next 60 days or sooner. We see this molecule as another addition to our ever-growing portfolio of affordable generic products," according to Jim Meehan, Vice President of Sales and Marketing for RPI.

Ranbaxy Pharmaceuticals Inc. ("RPI") based in Jacksonville, Florida, is the 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 34 countries and manufacturing operations in 7 countries.

For further information please contact:

Ramesh L. Adige
Vice President - Corporate Affairs
Ranbaxy Laboratories Ltd.
No 19, Nehru Place,
New Delhi -110019
Tel : +91-11-26464037
e-mail: ramesh.adige@ranbaxy.com

or

Krishnan Ramalingam
Manager- Corporate Communications
Ranbaxy Laboratories Ltd.
No 19, Nehru Place,
New Delhi -110019
Tel: +91-11-26002075
e-mail: krishnan.ramalingam@ranbaxy.com

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