Dual Status Rx/OTC Plan B In The Works? Barr Weighs Its Options
This article was originally published in The Tan Sheet
Barr hinted that it is leaning toward a dual label Rx/OTC approach in seeking FDA approval to switch the Plan B "morning after" pill
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FDA believes additional information on whether a drug can be marketed both Rx and OTC for the same indication is needed before a decision can be reached on Barr Labs' switch application for Plan B
An FDA decision on OTC availability of Barr Labs' Plan B emergency contraceptive is expected by the end of January
Dual Rx/OTC labeling for the Plan B emergency contraceptive may have similar implications for medications that are already available over the counter, according to an editorial in the June 3 New England Journal of Medicine