Gynetics Exec Supports Restricted Access For OTC Emergency Contraceptives
Emergency contraceptive maker Gynetics would support age requirements and other restrictions on over-the-counter access to emergency contraception products, Gynetics Chief Financial and Operating Officer Jack Stover suggested to an FDA Rx-to-OTC switch public meeting June 29.
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The discussion of switching cholesterol agents to over-the-counter status may reflect the failure of physicians to provide adequate counseling to patients, FDA Center for Drug Evaluation & Research Director Janet Woodcock, MD, told the agency's OTC switch public hearing June 29.
Women's Capital Corp.' s Plan B (levonorgestrel) emergency contraception, approved by FDA July 28, produced less nausea and vomiting than the Yuzpe levonorgestrel/estradiol regimen, currently marketed by Gynetics as Preven.
A consumer advertising campaign for Gynetics' emergency contraceptive Preven will begin in October, following distribution of the ethinyl estradiol and levonorgestrel four-pill regimen and pregnancy test kit, the company said.