Muro/Adams Tri-Nasal Launch Planned For Fall Allergy Season With 250 Reps
Muro Pharmaceuticals is increasing production to launch its Tri-Nasal intranasal steroid medication by the start of the fall allergy season.
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A crossover study may be one way to show dose response in bioequivalence studies for inhaled corticosteroids, members of the Orally Inhaled & Nasal Drugs Subcommittee of FDA's Pharmaceutical Sciences Advisory Committee agreed at a recent meeting.
Inhaled and intranasal corticosteroid products that have demonstrated no effect on pediatric growth should be exempt from FDA's new class labeling for the asthma and allergy drugs, Schering-Plough maintained.
Suppression of growth velocity in pediatric asthma patients should not discourage the first-line use of inhaled corticosteroids, FDA's Pulmonary & Allergy and Endocrine & Metabolism Drugs Advisory Committees determined July 31 at a joint meeting.