In a December 23 Federal Register notice, FDA is proposing to revise existing regulations on prescription fixed-combination drugs and establish new provisions applicable to prescription and nonprescription fixed-combination and co-packaged drugs and combinations of active ingredients under consideration for inclusion in an OTC monograph. Fixed-combination or co-packaged drugs are intended to provide greater effectiveness – either by having a greater effect for a single indication or by treating more than one indication – than either ingredient alone, or by having one active ingredient enhance the safety or effectiveness of another active ingredient. For purposes of the proposed rule, the term “drug” includes biological products but does not include medical devices. Under the proposed rule, fixed-combination and co-packaged drugs will be generally recognized as safe and effective when three criteria are met: ● each active ingredient must make a contribution to the effect(s) of the combination, enhance the safety or effectiveness of an active ingredient, or minimize the potential for abuse of an active ingredient ● the combination of the active ingredients does not decrease the safety or effectiveness of any of the individual active ingredients, and ● the dosage of each active ingredient must be such that the combination is safe and effective and provides “rational concurrent therapy.” Comments can be submitted to the docket until March 22, 2016.
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