The Food and Drug Administration (FDA) announced a correction to a previous notice regarding the withdrawal of approval for 23 abbreviated new drug applications (ANDAs). These applications, held by companies like Fosun Pharma USA Inc., Baxter Healthcare Corp., Celltrion USA, and i3 Pharmaceuticals, were initially set to be withdrawn by August 28, 2024. However, because these companies asked in time not to have their ANDAs withdrawn, the approvals remain valid. This notice clarifies the error and ensures the continued approval of these drug applications.
Simple Explanation
The FDA accidentally said some medicine approvals were taken away, but actually, they're not. The companies that make these medicines asked not to lose their approval, and the FDA fixed the mistake and said, "Oops, you're still good to go!"