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JANSSEN's HISMANAL (ASTEMIZOLE) NON-SEDATING ANTIHISTAMINE IS "APPROVABLE"

Executive Summary

JANSSEN's HISMANAL (ASTEMIZOLE) NON-SEDATING ANTIHISTAMINE IS "APPROVABLE" at FDA; the product has had an NDA pending at the agency since 1985. The "approvable" designation indicates that the safety and efficacy review for the product has been successfully completed. The company is meeting with FDA to work out final labeling. FDA could be particularly sensitive to antihistamine labeling based on recent experiences with Tavist-1 claims, and the aggressive promotion of Rx antihistamines to consumers. Hismanal is now back in the running for the second entry into the non-sedating class behind Merrell Dow's Seldane (terfenadine). Seldane, with worldwide sales surpassing $ 230 mil. in 1987, has remained unchallenged on the non-sedating antihistamine market since 1985. Hismanal has been studied for a once-daily dosage. That could be a significant labeling advantage compared to Seldane, whose recommended dosage is 60 mg b.i.d. Schering-Plough has an NDA pending for its non-sedating antihistamine product Claritin (loratadine). Schering received an approval recommendation from FDA's Pulmonary-Allergy Drugs Advisory Committee last October. Hismanal obtained "approvable" status without review by the advisory committee. Both J&J and Schering are in clinicals with pseudoephedrine combinations of their respective products comparable to Merrell Dow's Seldane-D. Other non-sedating antihistamine products in development are Burroughs Wellcome's acrivastine in Phase III clinical trials and Pfizer's once-a-day cetirizine. Pfizer filed an NDA for its non-sedating product in July for 5 mg, 10 mg and 20 mg doses.
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