USA – FDA withdraws 5 opioid ANDAs for no REMS or reports

Five generic opioid drugs are being withdrawn from the market by the US Food and Drug Administration (FDA), according to a Federal Register announcement.

The action comes after the holders of the abbreviated new drug applications (ANDAs) “have repeatedly failed to file required annual reports for those ANDAs and have failed to satisfy the requirement to have an approved risk evaluation and mitigation strategy (REMS),” wrote FDA in announcing the withdrawal.

The latest action comes after the firms holding the ANDAs failed to respond to a published notice offering an opportunity for a hearing (NOOH) published in the 25 September 2020 Federal Register.  The firms waived their opportunity for the hearing by failing to respond, noted FDA. Additionally, the failure to respond also constitutes a “waiver of any contentions concerning the legal status of the drug products.”…