Santarus gets FDA OK for Zegerid chewable tablets for acid reflux

By E. Janene Geiss

Philadelphia, March 27 - Santarus, Inc. said the Food and Drug Administration has approved the company's New Drug Application for Zegerid with Magnesium Hydroxide (omeprazole/sodium bicarbonate/magnesium hydroxide) chewable tablets 40 mg/600 mg/700 mg and 20 mg/600 mg/700 mg, an immediate-release proton pump inhibitor.

The tablets were approved for all of the indications the company was seeking, according to a company news release.

"This approval is another regulatory milestone for Santarus and is our fourth NDA approved since mid-2004. Each of our NDAs has been approved within the initial 10-month review period under Prescription Drug User Fee Act guidelines, which we believe reflects the capabilities of our clinical, product development and regulatory teams and the overall quality of our submissions," Gerald T. Proehl, president and chief executive officer of Santarus, said in the release.

The company said it is reviewing the positioning and launch timing of the chewable tablet dosage form and does not anticipate a commercial launch of the product this year.

"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," Proehl added in the release.

Zegerid chewable tablets 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, officials said.

The Zegerid family of products, including capsule, powder for oral suspension and chewable tablet dosage forms, offer a distinct pharmacological profile - rapidly reaching maximal plasma levels in about 30 minutes and providing acid control with a median 24-hour gastric pH of greater than 4 ranging from 12.2 hours to 18.6 hours, depending on the strength and dosage form, after repeated once-daily dosing. The drug can be taken once-a-day anytime during the day on an empty stomach, at least one hour before a meal, officials said.

Santarus is a San Diego specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products that treat gastrointestinal diseases and disorders and enhance the quality of life for patients.

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