Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

In Recommending Flibanserin Approval, FDA Panelists Urge Alcohol Contraindication

Executive Summary

Panel’s vote to approve Sprout’s female sexual dysfunction drug is conditioned on a REMS and possible contraindication with alcohol use; questions about drug’s date rape potential, breast cancer finding in mice addressed.


Related Content

FDA Adds New Co-Primary Endpoint For Female Sexual Desire Drugs
FDA Reviewers Disagreed About Approval Of Sprout's Addyi
Valeant Still Holding Off On DTC Ads For Controversial Female Sex Pill
Women’s Intuition: What Approval Of Sprout’s Addyi Means For Sponsors
Valeant Buyout Brings Marketing Clout To Sprout And Addyi
Now Sprout Has To Sell Female Sexual Desire Drug Addyi
Sprout's Flibanserin Gets Reluctant Nod From FDA Panel, But REMS Needed
Flibanserin Risk Management Challenges: Can A REMS Prevent Alcohol Interactions?
Flibanserin Fails To Improve Sexual Desire, FDA Advisory Committee Says


Related Companies