The status of 101 pharmaceutical products that were recently taken off the Nigerian market has been officially clarified by the National Agency for Food and Drug Administration and Control (NAFDAC).
The agency said in a statement published on its official X account yesterday, that the action is intended to give industry stakeholders and the general public a better understanding of the regulatory actions taken against the listed products.
According to NAFDAC, the terms “withdrawn,” “suspended,” and “cancelled” each refer to different regulatory actions made to guarantee the safety, quality, and compliance of drugs, BrandSpur Nigeria news reports.
The organization revealed that: Products classified as
- “Withdrawn” have had their registrations voluntarily revoked by the Marketing Authorization Holders (MAHs), typically for strategic or commercial reasons rather than necessarily because of safety or efficacy issues.
- “Suspended” describes short-term registration halts, usually while regulatory or compliance concerns are being addressed, and
- “Cancelled” refers to medications whose approvals have been completely withdrawn, frequently due to significant infractions, inadequate manufacturing standards, or safety concerns.
Nigeria no longer permits the production, importation, distribution, or sale of these goods.
Publication of such lists is consistent with international best practices, NAFDAC stressed. It works to stop the spread of fake goods and make sure that deregistered or inferior goods don’t end up on store shelves or in the hands of customers.
For instance: antimalarials, antimicrobials, diabetes drugs, eye drops, and injectables, among other therapeutic classes.
Checkout the underlisted cases:
For business purposes, Healthline Limited and Sanofi Aventis Nigeria Ltd. voluntarily recalled the 40 mg/240 mg Artemether/Lumefantrine and ASAQ (Artesunate-Amodiaquine Winthrop) tablets, respectively. Since their registrations have been revoked, 400 mg tablets and suspension of flagyl are no longer authorized for manufacture or distribution.
After a regulatory review, Norditropin Growth Hormone Injectables were also taken off the market.
However, NAFDAC reaffirmed its dedication to public health and asked distributors, pharmacists, and healthcare professionals to remain informed and adhere to the most recent regulatory standards.
