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news.The FDA has placed Andrx Corporation's abbreviated new drug applications on hold after finding concerns in the manufacturing process at the company's facilities during an inspection that ended in May. Shares in the company fell nearly 20% after the announcement of the news.
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The regulator has designated Andrx with Official Action Indicated status, and has issued the company with a list of inspectional observations. Andrx has submitted a detailed response to these observations to the FDA, including a proposed corrective action plan, but the FDA has so far not commented on this response.
Andrx says that it is working to resolve the current good manufacturing practices (cGMP) issues at its facility as quickly as possible. However, it could not guarantee when the issues would be resolved, commenting that the issue was not entirely under its control.
The FDA could seek various sanctions against Andrx for violations of cGMP, or other applicable statutes and regulations. The range of possible sanctions includes, among other things, product recalls or seizures, fines, total or partial suspension of production and/or distribution, suspension of the FDA’s review of product applications, enforcement actions, injunctions and civil or criminal prosecution. Under some circumstances, the FDA also has the authority to revoke previously granted drug approvals.