Ranbaxy Laboratories Limited said that it has received approval from the US 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, US 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).
According to a company press release, 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.