Pharmaceutical Business review

Santarus wins approval for heartburn tablet

The company has already won approval for a capsule form of the drug and Gerald Proehl, president and CEO of Santarus, explained that the company would not immediately release the chewable tablet formulation.

“We are evaluating the positioning and launch timing of the chewable tablet dosage form and do not currently anticipate that the commercial launch of this product will occur in 2006. Given the general market preference for the capsule dosage form, our commercial launch plan is based on a strategy intended to maximize our resources, while best positioning Zegerid capsules for commercial success.”

The tablets are specifically 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).