FDA SETS ASIDE JULY 28 FOR ADDITIONAL ZOVIRAX Rx-TO-OTC SWITCH REVIEW; DUAL Rx/OTC STATUS SUGGESTED AS WAY OF KEEPING INSURANCE COVERAGE BY AMWA
Executive Summary
Burroughs Wellcome's antiviral Zovirax has been allotted additional time by FDA for a July 28 review of its potential Rx- to-OTC switch by the agency's Nonprescription Drugs Advisory Committee and the Antiviral Drugs Advisory Committee, according to a tentative list of advisory committee meeting dates.
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