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



Executive Summary

SCHERING LOTRIMIN A.S WILL BE FIRST OTC SIMULTANEOUSLY MARKETED in exactly the same dosage form and strength as a prescription version. FDA approved an Rx-to-OTC switch for three of five indications for the clotrimazole 1% product on Oct. 27: tinea pedis (athletes foot); tinea cruris (jock itch); and tinea corporis (ringworm). Schering will continue to market clotrimazole 1% as a prescription product for candidiasis and tinea versicolor. The OTC approval marks the end of over a year of discussion between Schering and FDA about the status of clotrimazole and the beginning of a new FDA policy on simultaneous prescription and OTC marketing. FDA announced in May that it will allow prescription and OTC marketing of the same product in the same dosage form and strength on a case-by-case basis ("The Pink Sheet" May 22, p. 3). Schering's supplemental NDA to move the three clotrimazole indications OTC, and the ensuing regulatory disagreement, was presumably the impetus for FDA's policy shift. After submitting the supplemental NDA in December 1987, the company was reportedly told by FDA that Lotrimin could not be marketed both Rx and OTC. FDA reportedly suggested that the product be marketed as an OTC, with the prescription uses handled in professional labeling. Schering's outside legal counsel, D.C. lawyer Peter Barton Hutt (Covington & Burling), questioned the legality of FDA's decision in a June 1988 petition to the agency ("The Pink Sheet" Jan. 9, 1989, T&G-6). * In announcing the Rx/OTC policy in May, FDA Associate Chief Counsel for Drugs David Adams said that different brandnames would be one of the agency's criteria for allowing simultaneous marketing. The closely related names for the OTC and prescription clotrimazole products, however, indicates that FDA may only require slight modifications to prescription tradenames. That policy could be important for a number of upcoming switches, such as ulcer drugs, where there is high brand recognition. The policy is particularly noteworthy for Schering and Marion, which have begun a campaign to reinforce the Carafate trade name prior to its anticipated OTC switch.

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




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