NAFDAC halts Artemether/Lumefantrine registration

The National Agency for Food and Drug Administration and Control (NAFDAC) has halted the registration of Multi-Dose Anti-Malarial (Artemether/Lumefantrine) dry powder for oral suspension.

The announcement was made in a public alert No. 01/2025, released on the agency’s website yesterday.

NAFDAC explained that the decision was made due to the instability of the reconstituted formulations, which could lead to a loss of efficacy over time.

According NAFDAC, the suspension applies to all locally manufactured and imported Multi-Dose Artemether/Lumefantrine dry powder for oral use.

“NAFDAC will no longer accept new applications, renewals, or variations for this product.”

According to the Agency, stability studies revealed that reconstituted Artemether/Lumefantrine oral suspension becomes unstable after mixing, leading to a loss

Ifeoma Nwovu