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🇹🇼 Taiwan /Health & Science

Taiwan FDA: ADHD Drug Lisdexamfetamine Supply Expected to Normalize by February 2025 Amid Quality Checks

From Liberty Times · () Chinese

Translated from Chinese, summarized and contextualized by DistantNews.

At a glance

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  • Taiwan's Food and Drug Administration (FDA) is addressing a shortage of the ADHD medication Lisdexamfetamine dimesylate 10mg, with the manufacturer expecting normal supply by February 2025.
  • The FDA is implementing batch-by-batch testing for imported drugs and has approved domestic manufacturing to ensure supply during the shortage.
  • The agency clarified that pharmacies face no risk of reimbursement cuts for dispensing alternative ADHD medications, assuring the public that domestic supply remains stable.

Taiwan's Food and Drug Administration (FDA) is managing a shortage of the ADHD medication Lisdexamfetamine dimesylate 10mg, with the manufacturer projecting a return to normal supply by February 2025. The drug has been under restricted supply due to concerns over nitrosamine impurities exceeding daily intake limits in certain batches.

The manufacturer estimates that normal supply can be restored by February next year.

— Lin Yi-chuFDA Drug Administration Division Director Lin Yi-chu discussing the expected timeline for the return of normal supply for the ADHD medication.

To ensure continued access for patients, the FDA is implementing a rigorous batch-by-batch testing protocol for all imported medications. Concurrently, the agency has approved the special manufacturing of the drug by a domestic pharmaceutical company to bridge the supply gap. This dual approach aims to maintain a stable supply chain while the manufacturer addresses the quality control issues.

We will conduct batch-by-batch inspections after the drug is imported and before it is supplied.

— Lin Yi-chuFDA Drug Administration Division Director Lin Yi-chu explaining the quality control measures in place during the shortage.

FDA Drug Administration Division Director Lin Yi-chu addressed concerns that pharmacies might hesitate to dispense alternative medications due to fears of reimbursement issues. She clarified that the National Health Insurance Administration has provided special codes and guidance to healthcare providers, ensuring that alternative medications are properly reported and will not be subject to reimbursement cuts. This assurance aims to prevent any undue hesitation in providing necessary treatments to patients.

There are no reimbursement concerns.

— Lin Yi-chuFDA Drug Administration Division Director Lin Yi-chu clarifying potential issues for pharmacies dispensing alternative medications.
DistantNews Editorial

Originally published by Liberty Times in Chinese. Translated, summarized, and contextualized by our editorial team with added local perspective. Read our editorial standards.

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