Barr, FDA Will Meet On Plan B Switch; Agency Says Rulemaking Not Needed
This article was originally published in The Tan Sheet
The approval process for the over-the-counter sale of Barr's emergency contraceptive Plan B could be "wrapped up in a matter of weeks if [Barr and FDA] work diligently" together, according to an FDA spokesperson
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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
Barr Laboratories' efforts to increase access to its emergency contraceptive Plan B should include measures to make the drug accessible to women who cannot afford the morning-after pill, some panelists said at a joint meeting of the Nonprescription Drugs and Reproductive Health Drugs advisory committees in Gaithersburg, Md. Dec. 16