💊FDA Notice on Drug Products Not Withdrawn for Safety Reasons
Determination That VOSOL (Acetic Acid, Glacial) 2% Otic Solution/Drops; and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Summary
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The FDA's notice directly impacts businesses through the continued approval of abbreviated new drug applications (ANDAs) for the listed drugs, ensuring that compliant businesses can market generic versions without safety concerns from prior withdrawals. This allows for market stability and potential revenue growth based on ongoing product availability.