Ranbaxy Laboratories, India’s major drug manufacturing company has just received the US Food and Drug Administration (FDA) final approval to manufacture and market its formulation for the treatment of major depressive disorders in adults. The drug comes in the form of tablets known as Sertraline Hydrochloride, and have to be taken in five doses from 25mg to 200mg.
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.
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.