The Food and Drug Administration’s “additional conditions of nonprescription use” proposed rule for making more drug ingredients available OTC in the US portends introducing additional labeling obviously different from current options allowed by the agency.
Petros Pharma Introduces AI As ACNU Option In Research For OTC Switch Of Stendra ED Drug
Petros is first to introduce an OTC switch labeling tool which could be the next obvious step hiding in plain sight – AI, which wasn’t noted in FDA’s ACNU proposal and hasn’t previously been linked to a switch.
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“Overall, no unexpected/new data or findings” were presented to Germany's Expert Committee for Prescription in the most recent Rx-to-OTC switch application for sildenafil (25mg and 50mg), according to medicines regulator BfArM, resulting in a third rejection in three years.