💊FDA Corrects Drug Approval Notice for Bausch & Lomb and Others
Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications; Correction
Summary
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on March 14, 2025 (90 FR 49), appearing on page 12163 in FR Doc. 2025-04106. The document announced the withdrawal of approval of eight abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of April 14, 2025. The document indicated that FDA was withdrawing approval of the ANDA 075819 for amantadine hydrochloride syrup, 50 milligrams/5 milliliters, held by CMP Pharma, Inc., 8026 East Marlboro Rd., P.O. Box 147, Farmville, NC 27828. Before FDA withdrew the approval of this ANDA, CMP Pharma, Inc., 8026 East Marlboro Rd., P.O. Box 147, Farmville, NC 27828, informed FDA that they did not want the approval of the ANDA withdrawn. Because CMP Pharma, Inc., timely requested that approval of the ANDA not be withdrawn, the approval is still in effect.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 notice involves the withdrawal and correction of approval for abbreviated new drug applications, affecting the drug market and compliance for businesses in the pharmaceutical industry. Companies may need to adjust their strategies based on these regulatory changes.