Glaxo's Temovate (clobetasol propionate) topical ointment and cream will enter the U.S. as a high potency steroid treatment for dermatologic conditions. The product, approved by FDA on Dec. 27, is indicated for short term treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses, FDA-approved labeling states. Both cream and ointment forms contain a concentration of 0.05% of the active ingredient. According to Glaxo, Temovate will be "the most potent corticosteroid available." By comparison, most formulations of hydrocortisone are in the 0.5 to 3% concentration range. The labeling states that Temovate treatment "beyond two weeks is not recommended, and the total dosage should not exceed 50 grams per week because of the potential for the drug to suppress the hypothalmic pitutitary adrenal (HPA) axis. These products are not recommended for use in children under 12 years of age." According to Glaxo, multicenter clinical trials involving over 1100 patients comparing Temovate to other corticosteroids showed that Temovate is "at the highest end of the potency spectrum." The firm said that the safety profile of Temovate is similar to that of other drugs of its class. FDA classified the product as a 1C drug, a new chemical entity representing little or no therapeutic advance. Glaxo said that clinical experience with Temovate has been accumulated over 12 years of marketing in 43 countires. U.S. distribution will begin in April, Glaxo said. The product will be priced to whslrs. at $11.28 for 15 grams and $15.60 for 30 grams of either cream or ointment. Temovate is an extension of Glaxo's line in the topical dermatologic market. The firm currently markets a 0.5% hydrocortisone product, Corticaine cream, which also contains dibucaine 0.5%.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.
