Ranbaxy receives tentative drug approval from USFDA

The US Food and Drug Administration (USFDA) has granted a tentative approval to Ranbaxy Laboratories Ltd for the manufacturing and marketing of its drug Nexium, popularly prescribed in the treatment of heartburn.

Announcing this here to the Bombay Stock Exchange (BSE) on Thursday, an official statement issued by Ranbaxy Laboratories said that the USFDA has granted approval on Nexium with Esomeprazole 20 mg (base) and 40 mg (base). Nexium is the registered trademark of Astra Zeneca.

According to the pharmaceutical marketing research major Intercontinental Market Services (IMS), in December 2007 Esomeprazole became the second largest selling drug in the US with total annual market sales touching $5.5 billion.

According to the statement, Ranbaxy believes that it has a FTF (First to File) status on the drug, providing it with a potential 180 days marketing exclusivity.

Esomeprazole is indicated for short-term treatment of erosive esophagitis and for treatment of heartburn and other symptoms associated with Gastroesophageal Reflux Disease (GERD.)

The manufacturing and marketing would be done by Jacksonville (Florida) based Ranbaxy Pharmaceuticals Inc., a wholly owned subsidiary engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.