FDA withdraws 5 opioid ANDAs for no REMS or reports

Regulatory NewsRegulatory News | 08 April 2021 |  By 

Five generic opioid drugs are being withdrawn from the market by the US Food and Drug Administration (FDA), according to a Federal Register announcement.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.”
In addition to failing to file the annual report required of ANDA holders, the notified firms also did not formulate REMS, “necessary for all the applicable listed drugs that the ANDAs in table 1 reference to ensure the benefits of the listed drugs outweigh the risks,” according to the notice.
Lavipharm Laboratories held one ANDA for four different transdermal fentanyl preparations. Lavipharm lists a New Jersey address in its ANDA application; the firm’s website indicates that the parent company is based in Greece. Its original ANDA action date was 2006.
The ANDA for another of the withdrawn products, an acetaminophen and codeine preparation, was held by Seattle-based Everylife, with an original ANDA action date of 1978.
The final three ANDAs for one tablet and two capsule formulations of acetaminophen, aspirin and codeine were all granted to Texas-based Scherer Laboratories, also in 1978.
This small round of withdrawals comes more than a year after FDA announced its plans to withdraw 249 ANDAs held by 89 companies, all after repeated failures to submit annual reports. (RELATED: FDA Seeks to pull nearly 250 ANDAs over unsubmitted annual reports, Regulatory Focus 08 January 2020)
Federal Register


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Tags: FDA, generics, opioids, REMS, US

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