HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Rx Extended-Release Guaifenesin Must Exit Market By November, FDA Says

This article was originally published in The Tan Sheet

Executive Summary

Single-ingredient, extended-release prescription guaifenesin products must be removed from the market by the end of November if they have not been approved by FDA, the agency states in Feb. 25 letters to 66 marketers and distributors of the drugs

You may also be interested in...



Adams May Cough Up Humibid As Product Confusion Congests Sales

Adams Respiratory Therapeutics is considering whether to stop offering its Humibid 1,200 mg guaifenesin product, which it markets voluntarily behind the counter, as it launches an over-the-counter version of the same product under the name Maximum Strength Mucinex

FDA Maps Pathways To Compliance At Unapproved Drugs Workshop

FDA plans to increase enforcement actions against marketed unapproved drugs in the coming year, but hopes to cooperate with firms willing to come to the table seeking approval for currently unapproved products

Adams’ Suit Could Delay ANDA For URL/Mutual’s Mucinex Generic

A lawsuit filed by Adams Respiratory Therapeutics could bring a stay of up to 30 months on FDA's approval of Mutual Pharmaceuticals and United Research Laboratories' application for a generic version of Adams' Mucinex extended-release expectorant product

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS129574

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