NAFDAC halts approval of multi-dose Artemether, Lumefantrine products

The National Agency for Food and Drug Administration and Control (NAFDAC) has reiterated its directive discontinuing the registration of multi-dose Artemether/Lumefantrine dry powder for oral suspension, citing concerns over the instability and reduced effectiveness of the medication after reconstitution.

In Public Alert No. 09/2026, the agency reminded the public that the regulatory action, first announced in February 2025, applies to all locally manufactured and imported multi-dose Artemether/Lumefantrine dry powder products used in treating malaria.

NAFDAC explained that stability studies showed that once reconstituted, the anti-malarial suspension becomes unstable and may lose its efficacy, potentially leading to treatment failure. The agency warned that reduced drug effectiveness could worsen illness, increase the risk of complications, delay recovery and, in severe cases, result in death.

As part of the directive, the regulator said it will no longer accept new, renewal or variation applications for the affected products. Manufacturers have instead been advised to produce safer alternatives, including dispersible tablets or single-dose powder or granules packaged in sachets.

The action covers all brands and all manufacturers and importers of the multi-dose Artemether/Lumefantrine dry powder oral suspension.

NAFDAC urged healthcare professionals and members of the public to report any suspected sale of the discontinued products, as well as substandard or falsified medicines, to the nearest agency office. Reports can also be made through its dedicated helpline or via email.

The agency said the reminder forms part of efforts to safeguard public health and ensure the effectiveness of malaria treatment across the country.