The FDA has granted tentative approval to Ranbaxy Laboratories’ abbreviated new drug application (ANDA) for generic Nexium capsules, the first approval of any generic version of the blockbuster drug.

Nexium is indicated for the short-term treatment of erosive esophagitis, maintaining symptom resolution and healing of erosive esophagitis and for treating heartburn and other symptoms associated with gastroesophageal reflux disease.

Ranbaxy said it was the first to submit an ANDA for generic Nexium (esomeprazole magnesium) 20- and 40-mg delayed-release capsules, potentially providing the company with 180 days of marketing exclusivity for its product upon launch.