Block Drug Aphthasol given priority approval for canker sore treatment Dec. 18.
Executive Summary
BLOCK DRUG APHTHASOL ORAL PASTE FOR APHTHOUS ULCERS is first prescription drug to be approved for the canker sore indication. Aphthasol (amlexanox oral paste, 5%) was approved Dec. 17 for "the treatment of aphthous ulcers in people with normal immune systems." Aphthasol will be marketed through Block Drug's Oral Health Care Division and will be launched "during calendar year 1997," the company said. Block Drug said that it "does not anticipate this product will have a material effect on sales and earnings."
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