GENERIC ALBUTEROL METERED-DOSE INHALER LONGER-TERM SAFETY STUDIES
Executive Summary
GENERIC ALBUTEROL METERED-DOSE INHALER LONGER-TERM SAFETY STUDIES in more patients for ANDA applications are suggested by Glaxo in an April 6 citizen's petition to FDA. Glaxo is seeking the withdrawal of the agency's interim bioequivalence guidance for generic albuterol metered-dose inhalers issued Jan. 27 ("The Pink Sheet" Feb. 7, p. 14).