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

GSK Wins First-Ever Voucher Race With Anti-Malarial Approval

Executive Summary

US FDA’s approval of tafenoquine for malaria settled a first-of-its-kind race: GSK beat 60 Degrees to market to claim a priority review voucher.

You may also be interested in...



Amivas’ Malaria Drug Approval Brings Orphan Exclusivity, But Priority Review Voucher Status Unclear

Amivas requested a US tropical disease PRV for intravenous artesunate but FDA has not yet made a decision on eligibility; approval appears to block La Jolla’s competing product, currently under review, for seven years.

Keeping Track: A Glut Of Big Approvals While Lartruvo Makes Its Market Exit

The latest drug development news and highlights from our US FDA Performance Tracker.

US FDA’s Record Tally Of NMEs Outpaces Ability To Issue Press Releases

US FDA may have set record for new drug approvals during 2018, but agency actually issued press releases highlighting approvals less often than it has in the past.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

RS150923

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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