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Zdrowie i gospodarka · 23/10/2013

FDA Clears Path for PARAFLEX (Chlorzoxazone) Tablets, 250 mg, to be Approved via Abbreviated New Drug Applications

The Food and Drug Administration (FDA) has determined that PARAFLEX (Chlorzoxazone) Tablets, 250 milligrams, was not withdrawn from sale due to safety or effectiveness concerns. This decision enables the FDA to potentially approve abbreviated new drug applications (ANDAs) for PARAFLEX (Chlorzoxazone) Tablets, 250 mg, provided all other regulatory requirements are fulfilled.

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