Pink Sheet is part 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

UsernamePublicRestriction
UsernamePublicRestriction

REMS For Qsymia Limits Distribution, But Vivus To Explore Expanding Access

Executive Summary

Qsymia will launch through certified mail-order pharmacies, but FDA has asked the sponsor to look for ways to expand into the retail space with pharmacies that can meet requirements for distributing patient risk information and keeping track of prescribers.

You may also be interested in...



Women’s Intuition: What Approval Of Sprout’s Addyi Means For Sponsors

Filing for a drug with questionable risk-benefit profile was saved by a trial protocol redesign, strict safety labeling for a narrow indication, a REMS, patient mobilization and plenty of postmarketing studies. Trial period echoes FDA’s approach with a similar sector of lifestyle drug: obesity.

Specialty Pharmacies Could Be Selling Point If FDA Approves Tasimelteon

A Nov. 14 advisory committee gave near-unanimous support for Vanda’s sleep disorder drug on questions about its indication, endpoints, efficacy and safety.

With Another Push From Eisai, Can Arena’s Belviq Be A Blockbuster?

The Japanese pharma has expanded its collaboration with Arena for the obesity treatment Belviq, but the drug is off to a slow start in a market full of non-starters.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS054613

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel