April 15, 2014

Five US companies request voluntary withdrawl of antimicrobials

The US Food and Drug Administration (FDA) announced that five animal drug sponsors have requested to withdraw the approval of 19 animal drug applications, as the products are no longer manufactured or marketed.

Of these 19 applications, 16 are antimicrobials affected by the guidance GFI #213. The guidance signifies FDA's effort to curb the use of antibiotics in the country's livestock industry, as the connection between animal health and food safety is widely recognised.

FDA will update its chart of "Applications Affected by GFI #213" to reflect these withdrawals.