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

CFC-free inhalers

Executive Summary

GlaxoSmithKline is urging FDA and the Office of Management & Budget to issue final rule on ozone-depleting substances. The proposed rule, issued in September 1999, laid out FDA's suggested approach to phasing out metered dose inhalers that contain chlorofluorocarbons (1"The Pink Sheet" Sept. 9, 1999, p. 3). GSK met June 3 with representatives from OMB, Center for Drug Evaluation & Research Associate Director-Policy Jane Axelrad and Office of Drug Evaluation II Director Robert Meyer, MD, to discuss expediting the rule. The company launched the CFC-free inhaler Ventolin HFA (albuterol) in February, and is phasing out its CFC-containing Ventolin product...

You may also be interested in...



CFC-Containing MDIs Are "Essential" Until Multiple Alternatives Available

More than one CFC-free product alternative must be available before FDA phases out a CFC-containing metered dose inhaler that is available under multiple NDAs or in multiple strengths, the agency suggests in a proposed rule on ozone depleting substances (ODS) published in the Sept. 1 Federal Register.

Long Hot Summer For Novel Drug Reviews Forecast At US FDA

Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.

Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza

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

UsernamePublicRestriction

Register

PS040005

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