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Zdrowie i gospodarka · 18/02/2014

FDA Clears Path for Valproic Acid Delayed-Release Capsules to be Approved via Abbreviated New Drug Applications

The US Food and Drug Administration has ruled that STAVZOR (valproic acid) delayed-release capsules, available in 125mg, 250mg, and 500mg strengths, were not withdrawn from sale due to safety or efficacy concerns, paving the way for potential approval via abbreviated new drug applications.

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