💊FDA Finds VIBRAMYCIN Not Withdrawn, Impacts Generic Drug Market
Determination That VIBRAMYCIN (Doxycycline) for Oral Suspension, Equivalent 25 Milligrams Base/5 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Summary
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that VIBRAMYCIN (doxycycline) for oral suspension, equivalent (EQ) 25 milligrams (mg) base/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness.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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's determination that VIBRAMYCIN (doxycycline) was not withdrawn for safety or effectiveness means that generic manufacturers can continue to gain approval for abbreviated new drug applications (ANDAs), potentially increasing competition and pricing flexibility in the market for this drug. This could benefit business owners in the pharmaceutical industry by allowing them to enter or remain competitive in the market.