Santarus, Inc., a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for Zegerid (omeprazole/sodium bicarbonate) Capsules 40 mg/1100 mg and 20 mg/1100 mg, an immediate-release proton pump inhibitor (PPI). Zegerid capsules were approved for all of the indications the company was seeking.
"Market approval for Zegerid capsules is a significant milestone for Santarus, as it is the only immediate-release PPI in a capsule form. Capsules and swallowable tablets constitute the vast majority of the greater than $12 billion U.S. market for prescription PPIs," said Gerald T. Proehl, president and chief executive officer of Santarus. "Therefore, we believe Zegerid capsules will provide physicians with an immediate-release PPI in their preferred dosage formulation."
Zegerid capsules are indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), 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).
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