Zdrowie i gospodarka · 04/02/2019

FDA Clears Way for Pirfenidone Approval

The FDA has determined that ESBRIET (pirfenidone) film-coated tablets, 534 mg, were not withdrawn from sale due to safety or effectiveness concerns, paving the way for potential approval of abbreviated new drug applications.

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

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