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

MILES MYCELEX-7 (CLOTRIMAZOLE) OTC VAGINAL TAB/CREAM ADDS VAGINAL CANDIDIASIS INDICATION; MEAD JOHNSON PROMOTING Rx ANTIFUNGAL VAGISTAT-1 AGAINST NEW OTCs

Executive Summary

Miles is adding a new indication and dosage form of its Rx-to- OTC switch drug, clotrimazole. Supplemental NDAs for Mycelex-7 (clotrimazole) 100 mg tablet and 1% cream were approved for treatment of vaginal candidiasis on Dec. 26. Mycelex-7 is the third prescription treatment for yeast infections to go over-the-counter in a little more than a year. Schering-Plough gained OTC approval on Nov. 30, 1990 for its clotrimazole product Gyne-Lotrimin, which is available as a 1% cream and 100 mg vaginal tabs. Ortho followed suit with a Feb. 15, 1991 approval for Monistat 7 (miconazole) in 2% cream and 100 mg vaginal inserts. Both Gyne-Lotrimin and Monistat have been extensively promoted to consumers in print and TV ads and have had strong first-year sales. OTC Gyne-Lotrimin sales, for example, topped $100 mil. in 1991. Miles has not disclosed marketing or pricing plans for Mycelex-7. Miles first received approval to market 1% clotrimazole OTC as a treatment for ringworm, jock itch and athlete's foot on April 1, 1991. The firm submitted a supplemental NDA in the autumn of 1990 for OTC Mycelex in cream and liquid forms. The company markets prescription clotrimazole as Mycelex-G in 100 mg and 500 mg vaginal tablets and a 1% vaginal cream. Bristol-Myers Squibb's Mead Johnson Labs is promoting the advantages of a single-dose prescription drug compared to OTCs for the treatment of vulvovaginal yeast infections with the introduction of Vagistat-1 (tioconazole 6.5%). The OTCs are used in a seven-day treatment course. Mead Johnson said that Vagistat-1's recommended retail price of $24.07 is sometimes less expensive than OTC antifungals and noted that, unlike the OTC products, the consumer cost for Vagistat-1 is usually covered by health plans. Mead Johnson also is emphasizing the convenience of Vagistat-1 as "the only one-dose ointment for vaginal yeast infections." The product consists of a pre-filled applicator with approximately 4.6 grams of ointment containing 300 mg of tioconazole. Ads for Vagistat-1 will run in ob/gyn journals. Bristol-Myers Squibb licensed the drug from Fujisawa Pharmaceutical, which had marketed the product under the tradename Vagistat since October 1989. Fujisawa obtained the U.S. marketing rights to the antifungal from Pfizer in May 1989.

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

LL009864

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