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Zdrowie i gospodarka · 22/08/2019

FDA Clears ZONEGRAN (Zonisamide) 50mg Capsules for Continued Sale

The US Food and Drug Administration (FDA) has ruled that ZONEGRAN (Zonisamide) 50mg capsules were not withdrawn from the market due to safety or efficacy concerns. This decision means the FDA will not initiate withdrawal procedures for abbreviated new drug applications (ANDAs) referencing this product, and will continue to approve new applications as long as they meet regulatory requirements.

Source: Federal Register — Food and Drug AdministrationOpen original release →