NAFDAC clarifies status of 101 delisted drugs

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a detailed clarification on the status of 101 drugs recently withdrawn, suspended, or cancelled from the Nigerian market.

In a statement posted on its official X handle on Tuesday, the agency said the clarification aims to help the public and stakeholders better understand the implications of each regulatory action.

According to NAFDAC, the terms “withdrawn,” “suspended,” and “cancelled” reflect distinct regulatory decisions designed to uphold drug safety, quality, and compliance.

It explained that a “withdrawn” status applies to products voluntarily discontinued by their marketing authorisation holders, usually for commercial or market-related reasons, and not necessarily due to safety issues. “Suspended” refers to temporary halts in registration pending compliance, while “cancelled” means full revocation of approval—often over safety, quality, or poor manufacturing concerns.

NAFDAC said the publication of such lists aligns with global best practices, helping prevent counterfeit distribution and ensuring delisted products do not remain in circulation.

The affected products span various categories, including antimalarials, antimicrobials, diabetes medicines, eye drops, and injectables.

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are Artemether/Lumefantrine 40mg/240mg Tablets and ASAQ (Artesunate Amodiaquine Winthrop) Tablets, both voluntarily withdrawn for commercial reasons by Healthline Limited and Sanofi Aventis Nigeria Ltd, respectively.

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In the diabetes category, Januvia and Janumet have been withdrawn from the market, while Amaryl M Tablets and Amaryl M SR were voluntarily withdrawn by Sanofi Aventis.

NAFDAC reaffirmed its commitment to ensuring that all medicines available in Nigeria meet strict safety and quality standards to protect public health.