Merck Singulair Switch NDA Limits Indication to Allergies, Omits Asthma
This article was originally published in The Tan Sheet
Merck will try to convince an FDA advisory committee May 2 to partially switch its blockbuster Rx drug Singulair to OTC for allergy relief in adults only. The firm will not seek to switch the Rx indications for asthma or allergy relief in children.
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To fully capitalize on potential sales, Rx-to-OTC switch sponsors must plan marketing strategies years before a switch is proposed and continue for years after launch, IRI data shows. Other factors include working with managed care, product differentiation, pricing and consumer satisfaction.
Merck says it remains committed to retaining consumer care and animal health, though it continues to evaluate the businesses. Competitors such as Pfizer and Bristol-Myers Squibb successfully spun out non-pharma assets following similar restructurings.
FDA approved Merck’s overactive bladder drug Oxytrol for Women for OTC use, despite concerns raised by the Nonprescription Drug Advisory Committee in November. The company plans a launch in the fall.