Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Ranbaxy Pharmaceuticals, a wholly owned subsidiary of Ranbaxy Laboratories, has received tentative approval from the FDA for esomeprazole magnesium delayed-release capsules, 20mg and 40mg.
Subscribe to our email newsletter
Esomeprazole is a generic equivalent to Nexium which is indicated for the short-term treatment (four to eight 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.
Ranbaxy believes that it has a FTF (First to File) status on the drug, providing it with a potential 180 days marketing exclusivity, thereby offering a significant opportunity in the future.