NAFDAC Clarifies List of 101 Withdrawn Drugs and Their Current Status

The National Agency for Food and Drug Administration and Control (NAFDAC) has clarified the regulatory status of 101 withdrawn drugs in Nigeria, explaining the reasons behind each classification and reassuring the public of its commitment to drug safety and quality.

In a statement released on its official X (formerly Twitter) handle on Tuesday, the agency said the clarification was issued to help Nigerians and industry stakeholders understand the implications of the different categories under which these products were listed.

According to NAFDAC, the terms “withdrawn,” “suspended,” and “cancelled” represent distinct regulatory decisions made to ensure that only safe and compliant medicines remain in circulation.

Under its explanation, “withdrawn” refers to drugs whose registration was voluntarily discontinued by the manufacturer or marketing authorisation holder, often for commercial or market reasons, and not necessarily due to safety concerns.

Meanwhile, “suspended” denotes a temporary halt in registration pending compliance with regulatory standards, while “cancelled” applies to products whose approvals have been fully revoked — usually due to safety issues, poor quality, or non-compliance with manufacturing practices.

The agency stated that the publication of such lists aligns with global best practices, aimed at curbing counterfeiting and ensuring that delisted products do not re-enter the market.

NAFDAC provided examples across various categories, including antimalarials, antimicrobials, diabetes medicines, eye drops, and injectables.

Among the affected products are Artemether/Lumefantrine 40mg/240mg Tablets and ASAQ (Artesunate Amodiaquine Winthrop) Tablets, both voluntarily withdrawn by Healthline Limited and Sanofi Aventis Nigeria Ltd, respectively, for commercial reasons.

Other delisted medicines include Flagyl Suspension and Tablets (400mg), which are no longer approved for manufacture or sale, and Norditropin Growth Hormone Injectables, which were removed 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In the diabetes category, Januvia and Janumet were withdrawn from the market, while Amaryl M Tablets and Amaryl M SR were voluntarily withdrawn by Sanofi Aventis Nigeria Ltd.

Reaffirming its mandate, NAFDAC said,
“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.”