Nasalcrom single OTC use study "poses no barrier" to exclusivity award, FDA tells law firm.
This article was originally published in The Tan Sheet
Executive Summary
NASALCROM SINGLE OTC USE STUDY MEETS EXCLUSIVITY DATA CRITERIA required by the Waxman/Hatch Act, Center for Drug Evaluation & Research Director Janet Woodcock, MD, states in a Nov. 6 letter to the New York City-based firm Bass & Ullman. The one OTC use study conducted by McNeil Consumer Products in support of the allergy treatment/prevention product's Rx-to-OTC switch application was both "new" and "essential to approval" and thus satisfies the requirements for an award of three years of market exclusivity, FDA states.
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