India's drug major Ranbaxy Laboratories has received tentative approval from the US Food and Drug Administration to manufacture and market a pill to treat rhinitis, one of the most common illnesses in the US.
Affecting more than 50 million people in US, rhinitis is marked by bouts of sneezing and itching, or a runny or stuffy nose that do not seem to go away.
Total annual market sales for the approved drug Fexofenadine Hydrochloride tablets were $931 million last year.
"We are pleased to receive this tentative approval for Fexofenadine Hydrochloride Tablets. This product represents a future opportunity for Ranbaxy and will be launched following final approval from the FDA," said Jim Meehan, Vice President of Sales and Marketing for Ranbaxy Pharmaceuticals Inc (RPI) Friday.
"This will further expand our product portfolio of affordable generic alternatives which have a favorable impact on the economics of the US healthcare system," he said.
Based in Jacksonville, Florida, RPI is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.