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Pharmaceutical, Inc. However, because Breckenridge Pharmaceutical requested to keep their approval before it was withdrawn, the FDA has corrected this, and the approval of ANDA 209325 remains in effect.
Simple Explanation
Imagine a big mistake was made when some medicine approvals were taken back. One company, Breckenridge, didn't want their approval taken back, and they told the right people in time, so their permission to make the medicine is still good.