Aventis Amaryl
Executive Summary
FDA objects to claims made by Aventis sales aid and website that the company's diabetes drug "Amaryl is tailored to demonstrate an insulin-sensitizing effect," and "Tailor glucose control with Amaryl means...improving insulin sensitivity and targeting insulin resistance." The claims are misleading because "they strongly suggest that Amaryl works primarily by improving insulin sensitivity and targeting insulin resistance when such is not the case," FDA told the company in a March 8 letter. FDA also cited a sales aid for claiming that Amaryl causes a 3.7% decrease in HbA1c based on a 30-patient study. The agency notes that "the average net reduction in HbA1c with Amaryl in 720 patients treated with once daily was 2% compared with placebo-treated patients." FDA asked Aventis to discontinue promotions making such claims
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