FDA Revokes Five ANDAs for Generic Opioids
The FDA has withdrawn five generic opioids from the U.S. market, after three sponsors failed to meet regulatory requirements for their abbreviated New Drug Applications (ANDAs).
The companies repeatedly failed to file required annual reports for the ANDAs and to “satisfy the requirement to have an approved risk evaluation and mitigation strategy (REMS),” the agency said.
The FDA said the sponsors failed to respond to a Sept. 25, 2020, Federal Register notice that offered an opportunity to seek a hearing, and the failure constituted “a waiver of any contentions concerning the legal status of the drug products.”
The drugmakers whose ANDAs were revoked are Lavipharm Laboratories of East Windsor, N.J., Scherer Laboratories, based in Plano, Tex., and Everylife of Seattle, Wash.