Rx-to-OTC straight switch requires efficacy supplement -- final MaPP.
This article was originally published in The Tan Sheet
Executive Summary
Rx-TO-OTC SWITCH EFFICACY SUPPLEMENT APPLICATION is the appropriate format for products switching in the same dosage form or route of administration, according to FDA's final internal guidelines on Rx-to-OTC switches. The Manual of Policies and Procedures (MaPP) for OTC NDA and Rx-to-OTC switch review processes, issued Jan. 15, states: "An efficacy supplement should be submitted to an approved NDA for an Rx product if the sponsor plans to switch the drug product...in its entirety without a change in the previously approved dosage form or route of administration."