Dual Rx/OTC Status In US ‘Additional Condition’ Switch Proposal: Necessary Or Questionable?
FDA Shift In Requirements For OTC Switch Follow-On Approvals Also Discussed By Experts
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.