FDA grants Ranbaxy tentative approval for generic Nexium

PRINCETON Ranbaxy Laboratories has received tentative approval from the Food and Drug Administration for esomeprazole magnesium delayed-release capsules, 20 mg and 40 mg. This is the generic version of AstraZeneca’s drug Nexium.

Nexium 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.

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

Nexium is the second-largest selling drug in the U.S., with total annual market sales of $5.5 billion, according to IMS Health.