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

FDA Final Rule For OTC Inhaler Labeling Requires Death Warning

This article was originally published in The Tan Sheet

Executive Summary

FDA disagrees with industry comments regarding the health risks of using OTC asthma inhalers, rejecting suggested language for the final monograph covering asthma and bronchodilator drugs.

You may also be interested in...



Armstrong Says FDA "Assured" OTC Access Of Reformulated Primatene Mist

Armstrong Pharmaceuticals says FDA "assured" the firm that it can sell a proposed reformulated epinephrine inhaler OTC, if approved, despite opponents who say asthma relief is an inappropriate self-medication indication

FDA-Proposed Warning For OTC Bronchodilators “Alarming” – Wyeth

FDA should re-word a cardiovascular warning statement it has proposed for OTC bronchodilator products because the statement is "unnecessarily alarming" and "goes beyond that which is supported by data," Wyeth Consumer Healthcare maintains

NaZura’s Lovidia Weight-Loss Supplement Strategy Focused On Brand Building

NaZura BioHealth, spun out from Elcelyx Therapeutics, will market its Lovidia weight-loss product in 2014 when it launches into the direct-response channel, before potential suitors get serious about acquiring the brand.

Topics

UsernamePublicRestriction

Register

PS105209

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