Notice 9 May 2025 regulatory compliance, healthcare, fda, pharmaceutical industry, drug approval, andas

💊FDA Notice on Drug Products Not Withdrawn for Safety Reasons

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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.

Learn More
Notice 9 Apr 2025 healthcare, regulations, fda, pharmaceutical, drug approval, andas

💊FDA Finds VIBRAMYCIN Not Withdrawn, Impacts Generic Drug Market

The Food and Drug Administration (FDA, Agency, or we) has determined that VIBRAMYCIN (doxycycline) for oral suspension, equivalent (EQ) 25 milligrams (mg) base/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

Learn More