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

FDA's Dermatologic Drugs Advisory Committee

Executive Summary

Agenda for May 6 meeting includes potential safety issues concerning Reed and Carnrick's Rx anti-lice shampoo Kwell (lindane 1%) raised by new epidemiologic data suggesting an association between the shampoo and development of brain tumors in children. There will be closed committee deliberations in the morning with open discussion starting at 1 p.m. On May 7, beginning at 8:30 a.m., the committee will consider new indications for Schering's Elocon (mometasone furoate 0.1%) ointment and cream for use in children; and for pulse dose/maintenance therapy with high-and super-potent topical corticosteroids in treating psoriasis. Elocon is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The meeting will be held at FDA's Parklawn Building in Conference Rooms D & E.

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

PS142970

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