Allegra pediatric sNDA
Executive Summary
FDA adds data on pediatric patients ages six months to less than six years to Aventis' Allegra label May 12. Aventis conducted studies in response to written request by FDA. The company acknowledged that Allegra sales have been hurt by the inability to make a pediatric-friendly syrup formulation of fexofenadine (1"The Pink Sheet" May 12, p. 16)....
You may also be interested in...
Allegra Hurt By Stocking, Late Allergy Season, Not Other Products – Aventis
Aventis expects its allergy therapy Allegra to achieve single-digit growth in 2003 despite a slow first quarter, the company told analysts April 30
Biden Administration Is Setting An Example For Safe AI Use In Federal Organizations
A new memorandum by the Director of the Office of Management and Budget initiated a government-wide policy that will appoint AI officers to all agencies to address risks for AI use and serve as an example for greater AI adoption.
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.