USFDA grants tentative approval to Ranbaxy's esomeprazole magnesium DR capsules in the US
07 Feb 2008
The Florida-based Ranbaxy Pharmaceuticals Inc, wholly owned subsidiary of Indian pharmaceutical major Ranbaxy Laboratories has received tentative approval from the US Food and Drug Administration to manufacture and market esomeprazole magnesium delayed-release capsules in 20mg (base) and 40mg (base) strengths.
Astra Zeneca's Nexium (esomeprazole) is the second-largest selling drug in the US with total annual market sales of $5.5 billion (IMS - MAT: December 2007).
Ranbaxy says it believes that it has a first to file status on the drug, providing it with a potential 180 days marketing exclusivity, thereby offering a significant opportunity in the future.
Esomeprazole is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis, to maintain symptom resolution and healing of erosive esophagitis and for treatment of heartburn and other symptoms associated with Gastroesophageal Reflux Disease (GERD).
The US subsidiary is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.