Type:Notice
Citation:89 FR 107146
Reading Time:about a minute or two
The Food and Drug Administration (FDA) is withdrawing approval for two abbreviated new drug applications (ANDAs) from Flamingo Pharmaceuticals Ltd. This decision is because the company has consistently failed to submit the necessary annual reports for these drug applications. Despite being given a chance for a hearing, the company did not respond, resulting in a waiver of their hearing opportunity and any claims about the drug's legal status. Therefore, the approval for these drugs will officially be withdrawn on December 31, 2024.
Simple Explanation
The FDA, which makes sure medicines are safe, decided to stop letting Flamingo Pharmaceuticals sell two of their medicines because the company didn't send in their homework about the medicines on time.