PRINCETON, N.J., Feb. 8 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received final approval from the U.S. Food and Drug Administration 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(R) 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 correspond 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 RPI.
Source: Ranbaxy Pharmaceuticals