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6/17/2004

Oral Omeprazole Powder OK'd by FDA

Cheryl A. Thompson

A formulation of omeprazole meant for preparation as an oral suspension has been approved by the Food and Drug Administration (FDA) for marketing by Santarus Inc., the company announced Tuesday.

According to the company, omeprazole powder for oral suspension 20 mg was approved for three uses: treatment of heartburn and other symptoms associated with gastroesophageal reflux disease, treatment and maintenance of healing of erosive esophagitis, and treatment of duodenal ulcers.

The company's announcement stated that the formulation includes an antacid to protect omeprazole from degradation by stomach acid and that users prepare their once-daily dose by adding water to make a suspension.

Santarus President Gerald T. Proehl, during a webcast Wednesday, said the company will start selling the product in the fourth quarter of 2004.

The product lacks an official brand name, however. Proehl said FDA asked the company to pursue a brand name other than Rapinex, which the company continues to use in its announcements while acknowledging the need to select a final name.

"We currently are discussing two alternative brand names of the product with the FDA: a variation of Rapinex, and Zegerid, which the FDA has already approved," Proehl said. "We will select the final name prior to commercial launch and, importantly, we do not anticipate that the brand name selection process will impact our planned launch timing."

Meanwhile, FDA's online catalog of products with approved labeling recognizes Zegerid as the brand name for Santarus's omeprazole product.