The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a clarification regarding the status of 101 pharmaceutical products recently listed as withdrawn, suspended, or cancelled.
In a statement released on its official X handle on Tuesday, the agency said the clarification aims to help the public and stakeholders better understand the regulatory implications of each category.
According to NAFDAC, the terms “withdrawn”, “suspended”, and “cancelled” describe different regulatory actions taken to ensure drug quality, safety, and compliance.
“‘Withdrawn’ refers to products whose registration was voluntarily discontinued by the marketing authorisation holder, often for commercial or market-related reasons and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 concerns,” the statement read.
It added that “suspended” products are those with temporarily halted registrations pending regulatory compliance, while “cancelled” products are those whose approvals have been fully revoked due to safety, quality, or poor manufacturing issues.
The agency explained that publishing such lists aligns with global best practices to prevent counterfeiting and ensure that delisted or unapproved products do not remain in circulation.
Among the affected products are Artemether/Lumefantrine 40 mg/240 mg Tablets and ASAQ (Artesunate Amodiaquine Winthrop) Tablets, both voluntarily withdrawn by Healthline Limited and Sanofi Aventis Nigeria Ltd for commercial reasons.
Also affected are Flagyl Suspension and Tablets (400 mg), which have been cancelled and are no longer approved for manufacture or sale, and Norditropin Growth Hormone Injectables, which were delisted after a regulatory review.
In the diabetes treatment category, Januvia and Janumet have been withdrawn, while Amaryl M Tablets and Amaryl M SR were voluntarily delisted by Sanofi Aventis Nigeria Ltd.
NAFDAC reaffirmed its commitment to public safety and regulatory vigilance, assuring Nigerians of continued post-market surveillance to ensure that only safe, quality, and efficacious products are available in the country.
“NAFDAC remains committed to safeguarding the health of Nigerians through continuous post-market surveillance and regulatory enforcement,” the statement said.
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