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

UsernamePublicRestriction
UsernamePublicRestriction

US OTC Decisions In July: Labeling For Advil Sinus In 2-Count Packages, Lansoprazole, Ibuprofen

Executive Summary

Total of approvals for label changes for three OTC products in July equals the number CDER made for nonprescription products in the same month in 2019. July updates include approval of an sNDA for labeling for Advil Sinus Congestion & Pain tablets in packages containing two single-tablet pouches.

You may also be interested in...



Perrigo Feeds OTC Brand Play With Prevacid As GSK Thins Consumer Lineup

Already providing generic equivalents, Perrigo buys national brand from GSK as it acts on commitment to move into brand product sales. Plans to expand OTC Prevacid line, likely with an orally disintegrating tablet, and to grow entire US OTC gastrointestinal category.

FDA Wants Stronger Cardiovascular Warning For OTC NSAIDs

The agency says it will require stronger warnings about cardiovascular risks on prescription NSAIDS’ Drug Facts labels, but will request that OTC NSAID labels also are changed.

J&J’s Consumer Health Product Sales Slump In Comparison A Year After COVID-19 Stockpiling

Worldwide consumer health sales in January-March period were down 3.3% to $3.5bn with results off 7.4% to $1.6bn in the US and up 0.5% to $1.9bn internationally. However, excluding “COVID-19 comparison” in the year-ago period, the consumer health segment grew low-single-digits.

Topics

Related Companies

UsernamePublicRestriction

Register

RS150333

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