Ranbaxy Gains Final US FDA Approval For Sertraline Hydrochloride Tablets

Announced today that the Company has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Sertraline Hydrochloride Tablets 25 mg (base), 50 mg (base), 100 mg (base), 150 mg (base), and 200 mg (base).

GURGAON, India | Feb 08, 2007 |
Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market Sertraline Hydrochloride Tablets 25 mg (base), 50 mg (base), 100 mg (base), 150 mg (base), and 200 mg (base). The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulation to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Zoloft® Tablets 25 mg (base), 50 mg (base), 100 mg (base), 150 mg (base), and 200 mg (base) of Pfizer Pharmaceuticals, Inc. Total annual market sales for Sertraline Hydrochloride Tablets were $3.07 billion (IMS – MAT: September 2006).

Sertraline Hydrochloride Tablets are indicated for the treatment of major depressive disorder in adults whose diagnoses corresponds most closely to the DSM-III category of major depressive disorder.

“We are pleased to receive this final approval for Sertraline Hydrochloride Tablets. Ranbaxy now offers both solid and liquid dosage forms for this molecule that has established its utility and value in major depressive disorder. This product formulation will be launched immediately,” said Jim Meehan, Vice President of Sales and Marketing for Ranbaxy Pharmaceuticals Inc., USA.

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 8 countries.

SOURCE: Ranbaxy Laboratories Limited

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