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


Epinephrine metered-dose inhalers are nonmonograph effective June 19 -- FDA final rule.

This article was originally published in The Tan Sheet

Executive Summary

AEROSOL METERED-DOSE BRONCHODILATORS ARE NONMONOGRAPH EFFECTIVE JUNE 19 under a final rule published in the May 20 Federal Register. The rule amends the 1986 final monograph for OTC bronchodilators by removing pressurized metered-dose aerosol dosage forms of epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride. In addition, the rule adds "any ingredient(s) in a pressurized metered dose aerosol container" to the list of nonmonograph active ingredients for the category.

You may also be interested in...

People In Brief

Perrigo promotes in pricing, planning

In Brief

Combe sells most of its OTC brands

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC





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