New antiemetic gets FDA nod
Orally available Emend (aprepitant) from Merck has received FDA approval for use with other antiemetics for the prevention of nausea and vomiting associated with initial and repeated courses of moderately and highly emetogenic chemotherapy. The drug was tested in 866 breast cancer patients who had never before undergone emetogenic chemotherapy and was used in combination with ondansetron and dexamethasone. The new drug is available in 80- and 125-mg capsules with a recommended dose of 125-mg one hour prior to chemotherapy on day one, followed by 80-mg daily on days two and three of the treatment cycle.
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.
