💊FDA Confirms DECADRON Not Withdrawn for Safety or Effectiveness
Determination That DECADRON (Dexamethasone Sodium Phosphate) Solution/Drops, Equivalent to 0.1 Percent Phosphate, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Summary
The Food and Drug Administration (FDA, Agency, or we) has determined that DECADRON (dexamethasone sodium phosphate) solution/ drops, equivalent to (EQ) 0.1 percent phosphate, was not withdrawn from sale for reasons of safety or effectiveness.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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's determination allows for the continued approval of abbreviated new drug applications (ANDAs) for DECADRON, which may benefit generic drug manufacturers and impact market competition in the pharmaceutical industry. It also provides clarity for businesses interested in introducing similar products without the risk of regulatory withdrawal.