WASHINGTON, April 9 -- Food and Drug Administration has issued a notice called: GE HealthCare, et al.; Withdrawal of Approval of 18 New Drug Applications.
The notice was published in the Federal Register on April 9 by P. Ritu Nalubola, Associate Commissioner for Policy.
Summary: The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 new drug applications (NDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 51, Rm. 6226, Silver Sp...