Scrip 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

Mutual's colchicine product Colcrys approved for gout in US

This article was originally published in Scrip

Executive Summary

Mutual Pharmaceutical Company's Colcrys has become the first single-ingredient colchicine product approved by the US FDA for treatment of gout flares. The agency also licensed Colcrys for familial Mediterranean fever, an inherited inflammatory disorder, making it the first drug approved for this condition.

You may also be interested in...



COVID-19 Vaccines: Advisory Committee Picks Apart US FDA Guidance On Efficacy Endpoints

FDA's recommendation that COVID-19 vaccine sponsors conduct two months of median follow-up to support an emergency use authorization may not be long enough, some experts say in what can be viewed as validation for agency's position in battle with White House.

Cast Members In US FDA’s COVID-19 Vaccine Advisory Committee

There are 18 people on the committee that will issue the first recommendations on COVID-19 vaccine development and licensure. Among the experts are a University of Michigan epidemiologist who will serve as acting chairman and seven temporary voting members, two of whom required conflict-of-interest waivers.

Accelerated Approval Withdrawals Through The Years

Unlike AMAG's Makena, nearly all the products that have seen their accelerated approvals pulled have left the market quietly, our infographic shows.

Topics

Related Companies

UsernamePublicRestriction

Register

OM011995

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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