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FDA Approves New Formulation of Pantoprazole Sodium

MADISON, N.J., April 12 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE) , announced today that the U.S. Food and Drug Administration (FDA) approved the reformulation of the stomach acid suppressant, Protonix 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 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 I.V. formulation, which has been used clinically for seven years in more than five million patients worldwide.

"Protonix 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 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.

About Protonix I.V.
The FDA first approved Protonix I.V. in March 2001 for the short-term, treatment (7 to 10 days) of patients having gastroesophageal reflux disease (GERD) with a history of erosive esophagitis, as an alternative to oral therapy in patients who are unable to continue taking Protonix Delayed- Release Tablets. Safety and efficacy of Protonix I.V. as an initial treatment of patients having GERD with a history of erosive esophagitis have not been demonstrated.

Protonix I.V. received expedited FDA approval in October 2001 for the treatment of pathological hypersecretory conditions associated with Zollinger- Ellison Syndrome or other neoplastic conditions.

In clinical trials, the most frequently reported adverse events with Protonix I.V. were injection site reactions (including thrombophlebitis and abscess), headache, diarrhea, nausea, and dyspepsia. Protonix I.V. is contraindicated in patients with known hypersensitivity to any component of the formulation. Anaphylaxis has been reported. As with any other intravenous products containing edetate disodium, zinc supplementation should be considered in patients treated with Protonix I.V. who are prone to zinc deficiency. Treatment with Protonix I.V. should be discontinued as soon as the patient is able to be treated with Protonix Delayed-Release Tablets. For a copy of the full Prescribing Information, please visit .

Source: Wyeth

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