The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a clarification regarding the withdrawal of 101 drugs from the market.
In a statement posted on its official X handle on Tuesday, the agency said the clarification aims to help the public and stakeholders clearly understand the status and implications of each product category.
NAFDAC explained that the terms “withdrawn,” “suspended,” and “cancelled” represent separate regulatory measures intended to ensure the quality, safety, and compliance of pharmaceutical products.
According to the agency, “withdrawn” refers to products whose registration was voluntarily discontinued by the marketing authorisation holder, often for commercial or market-related reasons and not necessarily due to safety issues. “Suspended” indicates a temporary stop in registration until compliance requirements are met, while “cancelled” applies to products whose approvals have been permanently revoked, prohibiting their manufacture, importation, or sale—usually due to safety, quality, or poor manufacturing practices.
NAFDAC noted that publishing such lists follows global best practices designed to prevent counterfeiting and ensure that delisted products are not circulated within the market.
The affected products include various categories such as antimalarials, antimicrobials, diabetes medicines, eye drops, and injectables. Among them are Artemether/Lumefantrine 40mg/240mg Tablets and ASAQ (Artesunate Amodiaquine Winthrop) Tablets, both voluntarily withdrawn by Healthline Limited and Sanofi Aventis Nigeria Ltd for commercial reasons.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 delisted products include Flagyl Suspension and 400mg Tablets, which are no longer approved for production or sale, and Norditropin Growth Hormone Injectables, removed following a regulatory review.
In the diabetes category, Januvia and Janumet have been withdrawn, while Amaryl M Tablets and Amaryl M SR were voluntarily delisted by Sanofi Aventis Nigeria Ltd.
Reaffirming its commitment to public safety, NAFDAC stated:
“NAFDAC remains dedicated to protecting the health of Nigerians through continuous post-market surveillance and strict regulatory enforcement to ensure that only safe, high-quality, and effective products are available to the public.”