HBW Insight 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


Primatene Mist NDA Expected By July After FDA OKs OTC Asthma Inhaler Trial

This article was originally published in The Pink Sheet & The Rose Sheet

Executive Summary

Amphastar plans this month to begin what it expects to be its final study to support an NDA to relaunch Primatene Mist. If the results support accurate self-selection and usage of the product by consumers, Amphastar should be ready to re-submit the NDA during the current quarter.

You may also be interested in...

Primatene Mist TV Ads Coming To Boost OTC Emergency Asthma Inhaler's Sales

"We will begin TV advertising campaign in July, which we think will really increase awareness of the product and hopefully give a good return on investment on those commercials," says Amphastar president Jason Shandell. Returning recently relaunched product to Walmart,later in 2019 "should be a big boost for us because that was over 35% of sales previously," says CFO William Peters.

Primatene Mist CRL Underscores Challenges For OTC Asthma Treatments

Second FDA complete response letter for a reformulated Primatene Mist likely pushes back by another 18 months Amphastar's potential relaunch of the OTC product after satisfying the US agency's concerns about consumers correcting using the product without a doctor’s intervention.

Dry Powder Blows Dr. Natural OTC Epinephrine Inhaler Out Of Compliance

Dr. Natural Healing markets its Prime Asthma Relief Start Kit with an epinephrine delivery form – a capsule added to a dry powder inhaler – not approved under the OTC bronchodilator monograph, FDA says in a warning letter, its latest enforcement against OTC asthma inhalers it considers noncompliant.

Related Content


Related Companies




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