Washington: India's drug major Ranbaxy Laboratories hasreceived the US Food and Drug Administration (FDA)'s final approval tomanufacture and market its formulation for the treatment of major depressivedisorders in adults.

Ranbaxy Pharmaceuticals Inc. (RPI), a wholly ownedsubsidiary of Ranbaxy Laboratories Limited (RLL), announced Friday that FDAapproval permitted the Indian company to make Sertraline Hydrochloride tabletsin five doses from 25 mg to 200 mg.

"FDA's Office of Generic Drugs has determined the Ranbaxyformulation to be bioequivalent and have the same therapeutic effect as that ofthe reference listed drug Zoloft(r) of Pfizer Pharmaceuticals Inc.," it said.

Total annual market sales for Sertraline HydrochlorideTablets are estimated at $3.07 billion.

"We are pleased to receive this final approval forSertraline Hydrochloride Tablets. Ranbaxy now offers both solid and liquiddosage forms for this molecule that has established its utility and value inmajor depressive disorder. This product formulation will be launchedimmediately," said Jim Meehan, vice president of Sales and Marketing forRPI.

RPI based in Jacksonville, Florida, is engaged in the sale and distribution ofgeneric and branded prescription products in the US healthcare system.

"Ranbaxy's continued focus on R&D has resulted inseveral approvals in developed markets and significant progress in New DrugDiscovery Research. The company's foray into Novel Drug Delivery Systems hasled to proprietary 'platform technologies', resulting in a number of productsunder development," it said.