SANTARUS GETS FDA APPROVAL FOR ZEGERID CAPSULES

Santarus has announced that the FDA has approved the company's new drug application (NDA) for Zegerid (omeprazole/sodium bicarbonate) capsules, an immediate-release proton pump inhibitor (PPI). Zegerid capsules were approved for all of the indications the company was seeking.

Zegerid Capsules are indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease, the short-term treatment (four to eight weeks) of erosive esophagitis diagnosed by endoscopy and active benign gastric ulcers, the short-term treatment of active duodenal ulcers and for maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months).