Plan B Switch NDA Could Be Supported By New Study Findings
This article was originally published in The Tan Sheet
Executive Summary
Study results indicating a single 1.5 mg dose of levonorgestrel is as effective as two .75 mg doses 12 hours apart could help Women's Capital Corp. in its attempt to switch its emergency contraceptive Plan B over-the-counter
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Women's Capital Corporation's application to switch its Plan B emergency contraceptive from Rx to OTC status is expected to be considered by an FDA advisory panel in mid December
OTC Emergency Contraceptive Application Nearing FDA Panel Review
Women's Capital Corporation's application to switch its Plan B emergency contraceptive from Rx to OTC status is expected to be considered by an FDA advisory panel in mid December