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 MALE DESENSITIZING PRODUCTS CONTAINING LIDOCAINE OR BENZOCAINE

Executive Summary

OTC MALE DESENSITIZING PRODUCTS CONTAINING LIDOCAINE OR BENZOCAINE should not be required to carry a label warning concerning possible adverse effects on sperm and fertility, FDA said in a proposed rule for the OTC product class published in the Oct. 2 Federal Register. "The agency is aware of the ]OTC Miscellaneous External[ Panel's concern about the effect of benzocaine and lidocaine on sperm and the ovum (female egg). Although the Panel's proposed warning statement: 'The effect of this product on sperm and fertility has not been determined,' is intended to be informative, the agency believes that the warning would not achieve any useful purpose and may even be confusing to consumers," FDA said. FDA explained that "both benzocaine and lidocaine have a long history of topical use with relatively few side effects reported." The agency's Topical Analgesic Panel found the ingredients safe for use on the skin, mucous membranes and internally, FDA said, while the OTC Contraceptives and Vaginal Products Panel also found the drugs safe for intravaginal treatment of irritation. "Based on the many years of extensive marketing experience of products containing these ingredients, the recommendations of other advisory panels, and the lack of any data on adverse effects of these drugs on sperm and the ovum, the agency concludes that there is insufficient basis for the warning and is not including it in this tentative final monograph." The agency proposed only benzocaine (3-7.5% in water soluble base) and lidocaine (in a metered spray with approximately 10 mg/spray) for classification as Category I ingredients. FDA concurred with the panel's proposed classification in Category II of benzyl alcohol and ephedrine HCl, and placed camphorated metacresol, which was not classified by the panel, in Category II as well. The proposed Category I indication, FDA said, is: "Aids in the prevention of premature ejaculation." FDA also listed five optional statements which it said were appropriate, adding that other "truthful and nonmisleading statements, describing only the indications for use that have been established and listed ]in the proposed rule[ may also be used."

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

PS142351

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