SYNTEX' FEMSTAT ANTIFUNGAL CREAM IS "APPROVABLE" IN SUSTAINED- RELEASE
Executive Summary
SYNTEX' FEMSTAT ANTIFUNGAL CREAM IS "APPROVABLE" IN SUSTAINED- RELEASE formulation. Syntex currently markets Femstat (butoconazole nitrate 2%) with an indication for use once a day over three days, extendable by an additional three days, for the treatment of vaginal yeast infections. FDA designated the new formulation "approvable" on March 31, according to the agency's compilation of NDA approvals for that month (see FDA's list of March approvals, p. 12). The new sustained-release formulation incorporates K-V Pharmaceutical's proprietary Site Release technology and will allow Syntex to make a one-time dosing claim. Bristol-Myers Squibb already markets a single-dose prescription antifungal, Vagistat-1 (tioconazole 6.5%) under a license from Fujisawa. Syntex may be looking down the line to an OTC version; currently, both antifungals approved by FDA for OTC treatment of vaginal yeast infections -- Schering-Plough's Gyne- Lotrimin (clotrimazole 1%) and Ortho's Monistat-7 (miconazole 2%) -- require multiple applications.
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