FDA approval of stomach acid suppressant

Apr 12 2004

Wyeth Pharmaceuticals, a division of Wyeth, has announced that the U.S. Food and Drug Administration (FDA) approved the reformulation of the stomach acid suppressant, PROTONIX(R) I.V. (pantoprazole sodium) for Injection.

The reformulation eliminates the need for an in-line filter, a previously required extra step in an already time-sensitive procedure to administer the medication to patients requiring immediate acid suppression. PROTONIX(R) is the first and only proton pump inhibitor (PPI) in the United States to be offered in both oral and intravenous (I.V.) formulations.

The new formulation will replace the existing PROTONIX(R) I.V. formulation, which has been used clinically for seven years in more than five million patients worldwide. "PROTONIX(R) I.V., currently used in over 5,000 hospitals, has established a high standard of care for I.V. PPI therapy," said Joseph Camardo, M.D., Senior Vice President of Global Medical Affairs and Medical Director for Wyeth Pharmaceuticals North America. "Without the need for a filter, the reformulated product is more convenient for hospital pharmacists and nurses to use."

The new formulation has been approved for administration either as a 2-minute or 15-minute infusion. PROTONIX(R) I.V. received FDA approval in December 2003 for administration as a 2-minute infusion.

This alternative infusion approach may reduce drug preparation time and administration costs in hospitals, since the intravenous admixture bag can be replaced with a less expensive syringe for administration.