Another formulation cleared for Enbrel
Manufacturers Amgen and Wyeth have received approval from the FDA for a 25 mg/0.5 ml single-use prefilled syringe of etanercept (Enbrel).
Manufacturers Amgen and Wyeth have received approval from the FDA for a 25 mg/0.5 ml single-use prefilled syringe of etanercept (Enbrel). The new syringe will offer patients another dosing option and will make the fourth formulation available for the biologic. Etanercept is also available as a 50-mg/ml SureClick autoinjector, a 25-mg multiple-use vial, and a 50-mg prefilled syringe.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
