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

Asthma Sprays Primatene Mist, Asthmanefrin Await FDA Decisions

This article was originally published in The Tan Sheet

Executive Summary

Armstrong Pharmaceuticals waits to learn the fate of its recently submitted NDA for reformulated Primatene Mist, and Nephron Pharmaceuticals contests FDA’s September warning that its Asthmanefrin is an unapproved drug.

You may also be interested in...



OTC Emergency Asthma Inhaler NDA Survives, Needs Additional Studies

FDA’s request for additional data on Armstrong’s NDA for Primatene HFA – a breath-triggered, epinephrine inhalation aerosol – shows the agency’s interest in expanding consumers’ choices for OTC emergency asthma inhalers beyond the one currently available, racepinephrine with a battery-powered atomizer.

OTC Emergency Asthma Inhaler NDA Survives, Needs Additional Studies

FDA’s request for additional data on Armstrong’s NDA for Primatene HFA – a breath-triggered, epinephrine inhalation aerosol – shows the agency’s interest in expanding consumers’ choices for OTC emergency asthma inhalers beyond the one currently available, racepinephrine with a battery-powered atomizer.

Antiquated Nebulizers Deliver Uneven Asthma Doses – FDA Reviewers

Hand-held rubber ball nebulizers are “antiquated” and deliver inconsistently measured doses, FDA reviewers say in briefing materials prepared for a Feb. 26 advisory committee meeting to discuss removing the devices from the OTC monograph.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS106641

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