💊FDA Withdraws Approval of 23 ANDAs from Teva Pharmaceuticals
Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction
Summary
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on January 15, 2025. The document announced the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of February 14, 2025. The document indicated that FDA was withdrawing approval of the ANDA 209325 for miglustat capsule, 100 milligrams, held by Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Suite 201, Berlin, CT 06037. Before FDA withdrew the approval of this ANDA, Breckenridge Pharmaceutical, Inc. informed FDA that they did not want the approval of the ANDA withdrawn. Because Breckenridge Pharmaceutical, Inc., timely requested that approval of ANDA 209325 not be withdrawn, the approval is still in effect. This notice corrects this error.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's withdrawal of approval for 23 ANDAs may affect business owners in the pharmaceutical sector, particularly those holding applications that could face similar actions. Understanding regulatory compliance and monitoring for changes are essential for maintaining operational stability and avoiding potential financial impacts.