The first US approval for an actual use trial for an OTC switch of an erectile dysfunction drug has gone to Sanofi’s consumer business, Opella, a move that could signal the first proposal the Food and Drug Administration will consider as an “additional conditions for nonprescription use” switch.
First Green Light In US For ED Drug OTC Switch Actual Use Trial Goes To Opella For Cialis
ACNU Self-Selection Platform Becomes Full Focus Of US Firm Petros
Opella says FDA “lifted a clinical hold on its planned actual use trial to support the switch of Cialis” while Petros Pharmaceuticals shifts from working on its own ED-switch proposals to developing a proprietary technology-assisted platform designed for use in consumers’ self-selection of drugs made available in ACNU proposals.
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