The National Agency for Food and Drug Administration and Control (NAFDAC) has clarified the regulatory status of 101 pharmaceutical products recently listed as withdrawn, suspended, or cancelled, explaining that the action is aimed at strengthening public understanding and ensuring drug safety across Nigeria.
In a statement posted on its official X handle on Tuesday, the agency said the clarification became necessary to dispel misconceptions and guide healthcare providers, importers, and consumers on the implications of each classification.
According to NAFDAC, the terms “withdrawn,” “suspended,” and “cancelled” represent distinct regulatory actions taken to uphold product quality, safety, and compliance with national and international standards.
It explained that a product listed as “withdrawn” signifies a voluntary discontinuation by the marketing authorisation holder — often for commercial or strategic reasons, and not necessarily due to safety issues.
A “suspended” registration indicates a temporary halt pending compliance with regulatory requirements, while “cancelled” refers to products whose approvals have been permanently revoked, usually on account of safety, quality, or manufacturing concerns.
The agency noted that publishing such lists aligns with global best practices, helping prevent counterfeiting and alerting the public to products no longer authorised for sale or distribution in Nigeria.
Among the affected medicines are Artemether/Lumefantrine 40mg/240mg Tablets and ASAQ (Artesunate Amodiaquine Winthrop) Tablets, both voluntarily withdrawn by Healthline Limited and Sanofi Aventis Nigeria Ltd for commercial reasons.
Other drugs such as Flagyl Suspension and Tablets (400mg) have had their approvals fully cancelled, while Norditropin Growth Hormone Injectables were delisted following a regulatory review.
In the diabetes category, Januvia and Janumet were withdrawn from the market, while Amaryl M Tablets and Amaryl M SR were voluntarily discontinued by Sanofi Aventis Nigeria Ltd.
Reaffirming its commitment to public health, the agency stated:
“NAFDAC remains committed to safeguarding the health of Nigerians through continuous post-market surveillance and regulatory enforcement to ensure that only safe, quality, and efficacious products are available to the public.”
