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

Industry Wants Easier Path For OTC Drug Monograph, Labeling Changes

This article was originally published in The Rose Sheet

Executive Summary

Three over-the-counter drug marketers say FDA should develop an easier pathway for minor changes to OTC drug monographs in comments submitted to the agency. Providing input on how the agency can make its OTC drug review process more agile and efficient, the firms propose mechanisms for dosage-form variations and adding warnings to Drug Facts boxes on product labeling.

You may also be interested in...



HBW Executive Decisions: Perrigo Americas, Nutraceutical International Helm Changes, ABC Farnsworth Award, More

Myos Rens hires Eric LeGrand as special advisor for sports nutrition; Perrigo Consumer Americas chief Jeff Needham will be succeeded by Rich Sorota; Nutraceutical International appoints Monty Sharma to replace Chad Clawson at the helm; American Botanical Council’s Farnsworth Award goes to Rachel Mata; and Herbalife’s John Agwunobi will be chairman as well as CEO.

Bausch Expects US Approval In 2020 Of Preservative-Free OTC Ketotifen Eye Drop

Bausch says it expects US FDA to approve its ANDA for the first preservative-free OTC eye drop for ocular itching associated with allergic conjunctivitis in the second half of 2020. The firm reports its Lumify redness relief drops generated sales of $63m for 2019.

Prenatal Vitamin D Benefit In Preventing Childhood Asthma Fades By Age 6

University of Rochester researchers say a benefit of daily prenatal vitamin D in preventing asthma in children up to 3 found in their 2016 study doesn't extend until age 6. They encourage more research, including analyzing whether supplementation should continue in young children.

Related Companies

UsernamePublicRestriction

Register

RS019046

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