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Zdrowie i gospodarka · 16/11/2017

FDA Announces Final Decision on Mepergan Fortis Capsules Supplemental New Drug Application

The US Food and Drug Administration (FDA) has made its final decision on the supplemental new drug application (sNDA) for Mepergan Fortis Capsules, refusing approval due to insufficient evidence of its effectiveness for sedation and analgesia in patients with moderate pain and apprehension.

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