Protonix Withdrawn for Safety Reasons: FDA

FDA has denied petitions filed by Sun Pharmaceutical and Emcure Pharmaceuticals asking it to determine that Wyeth’s original Protonix IV for injection was not withdrawn for reasons of safety or efficacy and thus an ANDA could be filed citing the Wyeth formulation. The denial letter says that based on the nature of the potential safety risk associated with the original formulation, post-approval data confirming FDA’s initial concern about particulate formation when the lyophilized powder was diluted, the inability of labeling to adequately address the risk associated with the original formulation, and Wyeth’s currently marketed formulation’s elimination of the safety risk altogether, “FDA now concludes that any product that duplicates Wyeth’s original formulation would not be safe and that the original formulation of Protonix IV was discontinued for reasons of safety.”