Federal Register: FDA Issues Notice Confirming OZOBAX Was Not Withdrawn for Safety or Effectiveness
August 09, 2026
August 09, 2026
WASHINGTON, Aug. 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register.
* * *
The Food and Drug Administration (FDA) has determined that OZOBAX oral solution, 5 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (A . . .
* * *
The Food and Drug Administration (FDA) has determined that OZOBAX oral solution, 5 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (A . . .