FDA Approves CroFab Product Improvements

BTG announced that the US Food & Drug Administration (FDA) has approved updating the shelf life of CroFab Crotalidae Polyvalent Immune Fab (Ovine) to 60 months and the removal of mercury from the product's manufacturing process. The changes are part of the third update to the CroFab Prescribing Information in three years. CroFab is the only available FDA-approved product for the management of all North American pit viper envenomations in adult and pediatric patients.

The new 60-month shelf life for CroFab is a 24-month increase over the current 36-month shelf life. Increasing the shelf life will reduce the need to return expired product and help to ensure that hospitals have an adequate supply of the antivenom on hand for use in a potentially life-threatening situation.

The updated CroFab Prescribing Information approved by the FDA also removes all references to the product containing mercury and all warnings regarding mercury toxicity. The manufacturing process for CroFab previously involved the use of thimerosal, an ethyl mercury-containing compound, and trace amounts were carried into the final product. While this amounted to no more than 0.6 mg of mercury per dose (based on the maximum dose of 18 vials used in clinical studies of CroFab), the manufacturing process was changed to completely eliminate mercury-containing compounds.

"BTG continues to make investments in CroFab to help improve its safety, quality and efficacy," said Suzanne Ward, Senior Director of Medical Strategy for BTG Pharmaceuticals. "This is the latest in a series of label updates we've made over the last three years, and we continue to look for ways to meet the needs of patients and healthcare professionals. As the maker of the only available antivenom in the US to treat all species of pit viper envenomations, we feel it is critical to focus on the safety and reliability of our product."

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