India's drug major Ranbaxy Laboratories has received the US Food and Drug Administration (FDA)'s final approval to manufacture and market its formulation for the treatment of major depressive disorders in adults.
Ranbaxy Pharmaceuticals Inc. (RPI), a wholly-owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced Friday that FDA approval permitted the Indian company to make Sertraline Hydrochloride tablets in five doses from 25 mg to 200 mg.
FDA's Office of Generic Drugs has determined the Ranbaxy formulation to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Zoloft(r) of Pfizer Pharmaceuticals Inc., it said.
Total annual market sales for Sertraline Hydrochloride Tablets are estimated at $3.07 billion.
"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.
RPI based in Jacksonville, Florida, is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.
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, it said.