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

OTC Decisions August-October: More Providers Enter Diclofenac, Lansoprazole, Loratadine Markets

Executive Summary

CDER’s August-September OTC application approvals are highlighted by Arbor Pharmaceuticals’ ivermectin 0.5% lice treatment. Orange Book changes also include four firms’ approvals for labeling to market generic equivalents of Voltaren Arthritis Relief launched as an OTC switch since earlier in 2020.

You may also be interested in...



Traditional But Trendy: Capsules And Tablets Lead VMS Delivery Formats Despite Gummy Growth

Natural Marketing Institute survey found capsules (42%) and tablets (41%) are most popular supplement formats followed by gummies (35%). Results presented during a Council for Responsible Nutrition webinar showed younger consumers are willing to try formats such as tinctures, oral sprays and tablets.

Divided FTC Okays Mylan-Upjohn Merger But Election Outcome Could Impede Future Deals

Commissioners vote 3-2 that Mylan and Pfizer’s Upjohn can combine after divesting seven products; dissenting votes focus on price fixing allegations as commissioners Chopra and Slaughter criticize majority for not addressing government’s case against Pfizer and Mylan. Former FTC attorneys note that if Biden wins the presidential election, he could nominate one of the dissenters to FTC chair and give more traction to their views.

In Latest US OTC Switch, Ivermectin 0.5% Lice Treatment Becomes Fully Nonprescription

FDA approved Arbor Pharmaceuticals' sNDA for an OTC switch of Sklice lice treatment. As it's been prescribed since its 2012 approval, Sklice will be available as a single-use lotion for topical treatment of head lice infestations in patients six months of age and older.

Related Content

Topics

UsernamePublicRestriction

Register

LL1134420

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