FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: BAUSCH & LOMB INCORPORATED, ET AL.; WITHDRAWAL OF APPROVAL OF EIGHT ABBREVIATED NEW DRUG APPLICATIONS

WASHINGTON, March 14 -- Food and Drug Administration has issued a notice called: Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications.

The notice was published in the Federal Register on March 14 by P. Ritu Nalubola, Associate Commissioner for Policy.

Summary: The Food and Drug Administration (FDA or Agency) is withdrawing approval of eight abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

For more information, contact Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Ha...