Zdrowie i gospodarka · 21/11/2013

FDA Clears Path for BANZEL 100mg Tablets to be Approved via Abbreviated New Drug Applications

The FDA has determined that BANZEL (rufinamide) 100mg tablets were not withdrawn from sale due to safety or effectiveness concerns. This decision enables the FDA to approve abbreviated new drug applications for rufinamide 100mg tablets, pending compliance with all applicable regulations.

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

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