US FDA Checking Boxes On OTC Monograph Overhaul And In-Box For ACNU Switch Comments
‘Different’ OTC Space Coming From Monograph Program Reform, Proposed OTC Switch Changes
“Who would have said that, looking forward two or three years ago, we would be where we are now?” says FDA OTC office director Theresa Michele. Monograph reform and introducing “additional conditions for nonprescription use” options for NDA OTCs each is a “real gamechanger.”
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OTC drug development and marketing consultants discuss FDA allowing simultaneous Rx and OTC sales of same drug formulation with the same indication and about opportunities for follow-on generic equivalents of switches approved as additional condition for nonprescription use OTCs.
“Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFl isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.
Authorization was a long time coming for FDA to reform OTC monograph program and streamline process to change formulations, indications or labeling for large majority of drugs available nonprescription. As program is overhauled, monograph updates may seem to be coming just as slowly.