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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like Fosun Pharma USA Inc., Baxter Healthcare Corp., Celltrion USA, and i3 Pharmaceuticals, were initially set to be withdrawn by August 28, 2024. However, because these companies asked in time not to have their ANDAs withdrawn, the approvals remain valid.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.

The Food and Drug Administration (FDA) is withdrawing approval for 18 new drug applications because the companies that made them have told the FDA that they are no longer selling these drugs. The companies also asked the FDA to withdraw their drug approvals and agreed not to have a hearing about it. This means that starting from May 9, 2025, selling these drugs without approval would be against the law. However, any remaining stock of these drugs can still be sold until they are all gone, expire, or otherwise become non-compliant.

The Food and Drug Administration (FDA) has determined that DECADRON, a medication with the active ingredient dexamethasone sodium phosphate, was not taken off the market for reasons related to safety or effectiveness. This decision allows continued approval of generic versions of the drug as long as they comply with necessary legal and regulatory standards. DECADRON will remain on the "Discontinued Drug Product List," which includes drugs discontinued for reasons other than safety or effectiveness. The FDA reviewed data and found no evidence of safety concerns leading to the drug's withdrawal.