Discontinued Formulation of Protonix IV Is Unsafe for Generics, FDA Says

The FDA will not approve generics referring to the original and discontinued formulation of Protonix IV, after a review of scientific data confirmed that therapy for gastroesophageal reflux disease was pulled off the market for safety reasons.

FDA chemists observed a presence of solid and liquid particles above acceptable limits in the original formulation of Protonix IV that pose significant safety risk. As a result, the FDA denied petitions from Sun Pharmaceuticals and Emcure Pharmaceuticals to approve copycat versions of Protonix IV.

The FDA approved Protonix IV in 2001 for use with an in-line filter intended to remove any unsafe particles. A report submitted on the use of the filter indicated that 13 percent of pharmacists and 5 percent of nurses administered Protonix IV without it. Eighty-one percent of adverse reactions were linked to the improper use of the filter.