Oral Contraceptive Switch Advocates Reject User Age As Approval Factor
Executive Summary
FDA could soon receive an NDA from non-profit research group Ibis Reproductive Health and HRA Pharma, for an oral contraceptive switch in the US.
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Oral Contraceptive OTC Proposal Moves Closer With Start Of Actual Use Study
HRA Pharma started recruiting in April for an actual use trial, using oral contraceptives with norgestrel 0.075 mg, and expects to complete its study in April 2019, according to clinicaltrials.gov's database. Advocacy group Ibis Reproductive Health, which is working with HRA on an NDA for an OTC oral contraceptive, called the start of the study a "pivotal moment" in moving birth control drugs out of Rx-only.
Oral Contraceptive OTC Proposal Moves Closer With Start Of Actual Use Study
HRA Pharma started recruiting in April for an actual use trial, using oral contraceptives with norgestrel 0.075 mg, and expects to complete its study in April 2019, according to clinicaltrials.gov's database. Advocacy group Ibis Reproductive Health, which is working with HRA on an NDA for an OTC oral contraceptive, called the start of the study a "pivotal moment" in moving birth control drugs out of Rx-only.