New administration route for MDS therapy
Azacitidine for injection (Vidaza, Pharmion) can now be given intravenously according to the FDA. Instructions for the new route of administration will be added to the prescribing information, which includes the existing subcutaneous route instructions. Now, azacitidine can be infused over 10 to 40 minutes and the dosing will remain the same for both types of administration75 mg/m2 daily, for seven days, every four weeks. Azacitidine is approved for treatment of the five subtypes of myelodysplastic syndromes (MDS).
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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.
