Wyeth Pharmaceuticals' supplemental New Drug Application (sNDA) for room temperature shipping and storage of Protonix I.V. (pantoprazole sodium) for injection has been given approval by US FDA.
As a result of this approval, Protonix I.V. will be shipped to customers and can be stored at room temperature. Room temperature storage represents a substantial improvement with respect to how Protonix I.V. is stocked in hospital pharmacies and patient care areas. The Company expects to begin shipping room temperature storage Protonix I.V. in the first quarter of 2005, Wyeth informed.
Room temperature shipping and storage follows a series of product enhancements to Protonix I.V. since its introduction in April of 2001. Other improvements include a 2-minute infusion option and filterless administration. Administration of Protonix I.V. by the 2-minute infusion option may reduce drug preparation time and administration costs in hospitals. Also, filterless administration can contribute to ease of use when administering Protonix I.V. to hospitalized patients.
Protonix was the first proton pump inhibitor (PPI) in the US to be offered in both oral and I.V. formulations. Protonix I.V. has been used clinically in over five million patients worldwide, Wyeth said.