Rx-to-OTC switches: What FDA's new proposed rule means for pharma companies
As the FDA kicks off its review of a request to make the birth control pill an over-the-counter drug, the agency also recently unveiled a wide-ranging proposal that would speed up these prescription to OTC switches by offering an in-between pathway for drugs that can be marketed as both prescription and OTC drugs.
Current labeling limitations have led to challenges for sponsors attempting these Rx-to-OTC switches, FDA says, but the proposed rule from late last month would allow for the simultaneous marketing of the prescription and OTC versions of the same drug under what will be known as nonprescription drugs with an Additional Condition for Nonprescription Use (ACNU).
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