Scrip 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

Primatene OTC Asthma Inhaler Amended NDA Expected Second Quarter

This article was originally published in The Tan Sheet

Executive Summary

Amphastar Pharmaceuticals "recently received constructive comments from the FDA regarding our studies" and is "in the process of completing what we believe to be our final human factors study" before responding to a complete response letter the agency submitted in 2014, says company President Jason Shandell.

You may also be interested in...



Keeping Track: CDER 2016 Novel Approvals Hold At 22 As US FDA Declines Cempra's Solithera

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

With Pataday Extra Strength, Alcon Eyes Consumers Looking For OTC 24-Hour Eye Allergy Remedy

Pataday Once Daily Relief Extra Strength is the same formulation as Novartis' Rx Pazeo. It will be the first OTC eye drop indicated for allergy itch with 24-hour efficacy, available online in September and through retailers in early 2021.

US Appropriators Question FDA’s OTC Switch Process Overhaul, Homeopathic Market Oversight

Appropriations Committee’s report with Agriculture, Rural Development, FDA and Related Agencies FY2021 budget bill also reiterated concern about adding acetaminophen dosing information for children to OTC monograph. But its mentions of FDA initiative to expand ingredients available OTC and homeopathic market oversight were firsts.

Topics

Related Companies

UsernamePublicRestriction

Register

ID1131511

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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