Search Results for keywords:"withdrawal of approval"

The Food and Drug Administration (FDA) is withdrawing approval of seven new animal drug applications because the companies responsible for these drugs repeatedly failed to submit the required annual reports. The FDA had previously offered these companies the chance for a hearing, but they did not respond, which meant they gave up that opportunity and any arguments about the legal status of the drugs. As a result, these drug approvals will no longer be valid starting February 23, 2021.

The Food and Drug Administration (FDA) issued a correction notice regarding the withdrawal of approval for 23 abbreviated new drug applications (ANDAs), which was published in the Federal Register on January 15, 2025. Initially, it was stated that FDA was withdrawing the approval of ANDA 209325 for miglustat capsules held by Breckenridge Pharmaceutical, Inc. However, because Breckenridge Pharmaceutical requested to keep their approval before it was withdrawn, the FDA has corrected this, and the approval of ANDA 209325 remains in effect.

The Food and Drug Administration (FDA) has updated regulations to reflect the withdrawal of approval for seven new animal drug applications due to non-compliance with reporting requirements. This change means that certain firms are no longer recognized as sponsors for these drugs. The decision takes effect on February 23, 2021, and involves technical amendments to various parts of the Code of Federal Regulations to ensure accuracy. The rule does not impose any new burdens on businesses and is not subject to further review or certain regulatory requirements.