Pink Sheet 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 GLYCERIN/ALCOHOL COMBO FOR PREVENTION AND TREATMENT OF SWIMMER's EAR

Executive Summary

OTC GLYCERIN/ALCOHOL COMBO FOR PREVENTION AND TREATMENT OF SWIMMER's EAR will be placed in Category III in the OTC Products monograph, OTC Div. Director Gilbertson told Commerce Drug in a recent "feedback" letter. Gilbertson said that data submitted by the firm was insufficient to support the indication for its Auro-Dri otic product, and added that the division "intends to recommend to the Commissioner that the agency classify 5% anhydrous glycerin in 95% isopropyl alcohol in Category III for "'the prevention of swimmer's ear and treatment of water-clogged ears.'" Noting that the claims of prevention of swimmer's ear and treatment of water-clogged ears were not considered by the OTC Otic Products Panel, Gilbertson said "that final monograph will deal only with earwax removal aids." However, the FDAer said the agency "will publish a separate proposed rule to amend the final monograph in a future Federal Register" in order to obtain public comment on whether the claims should be added to the monograph. Gilbertson told the company that the clinical data submitted indicated that the product "was successful in drying more than 50% of the water in the ears of 42 out of 49 patients within a five minute period." He noted, however, that "the data provided do not address the question of the effectiveness in preventing swimmer's ear, because the data did not show prevention or a reduction in the incidence of swimmer's ear in a susceptible target population." In addition, Gilbertson said that although the firm claims Auro-Dri is a combination product, "the data did not show the effectiveness of each ingredient alone." Stating that each ingredient must be tested alone and in combination if therapeutic claims are made for both ingredients, Gilbertson said "if glycerin functions only as an inactive ingredient, additional testing would not be required for this ingredient."

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

OM017301

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