Search Results for keywords:"FDA withdrawal"

The Food and Drug Administration (FDA) has decided to withdraw its approval of the new drug application (NDA) for ZULRESSO (brexanolone) solution, which was previously held by Sage Therapeutics, Inc. This decision comes after Sage Therapeutics informed the FDA that the drug is no longer being sold and requested the withdrawal. The withdrawal of approval is effective as of April 14, 2025. It is important to note that any remaining ZULRESSO products can still be used until they are sold out, expire, or become unusable after the withdrawal date.

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 Therefore, the approval for these drugs will officially be withdrawn on December 31, 2024.

The Food and Drug Administration (FDA) has decided to withdraw its approval of 23 abbreviated new drug applications (ANDAs) after being informed by the applicants that these drug products are no longer being marketed. This withdrawal is effective from February 14, 2025. The applicants have waived their right to a hearing regarding this decision. According to the regulations, any remaining inventory of these products can be dispensed until it runs out, expires, or otherwise becomes non-compliant.