The National Agency for Food and Drug Administration and Control (NAFDAC) has clarified the status of 101 withdrawn drugs in Nigeria to improve public understanding and stakeholder awareness of the regulatory actions taken on these products. In a statement, the agency explained that the terms “withdrawn,” “suspended,” and “cancelled” represent distinct regulatory measures designed to ensure drug quality, safety, and compliance.
A “withdrawn” product is one whose registration has been voluntarily discontinued by the manufacturer, usually for commercial or market‑related reasons rather than safety concerns. “Suspended” products have had their registration temporarily halted pending regulatory compliance, while “cancelled” products have had their approvals fully revoked due to safety, quality, or poor manufacturing practices.
NAFDAC emphasized that publishing lists of withdrawn products is a global best practice aimed at preventing counterfeiting and ensuring that delisted items are removed from circulation. The agency provided examples across several categories, including antimalarials, antimicrobials, diabetes medicines, eye drops, and injectables. Notable cases are Artemether/Lumefantrine 40 mg/240 mg tablets and ASAQ (Artesunate Amodiaquine Winthrop) tablets, both voluntarily withdrawn by their manufacturers for commercial reasons. Other affected products include Flagyl suspension and tablets, which are no longer approved for manufacture or sale, and Norditropin growth hormone injectables, which were delisted after a regulatory review.
In the diabetes category, Januvia and Janumet have been withdrawn from the market, while Amaryl M tablets and Amaryl M SR were voluntarily withdrawn by Sanofi Aventis Nigeria Ltd. NAFDAC reaffirmed its commitment to public safety, stating that it “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.” This clarification underscores the agency’s effort to maintain transparency and protect public health by ensuring the removal of unsafe or ineffective drugs from the market.
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