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Executive Summary

MARION MERRELL DOW's SELDANE-D IS "APPROVABLE," the company announced July 1. FDA sent the firm an "approvable" letter for terfenadine and pseudoephedrine HCI extended-release tablets on June 12. Completion of a routine pre-approval inspection of the firm's Cincinnati plant appears to be the sole remaining hurdle before final approval of Seldane-D. In a July 1 release, Marion Merrell Dow President Fred Lyons said "final labeling has been resolved and the requisite plant inspections are under way. We expect these inspections to be completed in the near future." Marion Merrell Dow noted that it is still taking prelaunch orders for the new antihistamine/decongestant product. This firm still has a chance to get the product to the trade in time for the autumn allergy season. The company has been receiving orders since March 18 ("The Pink Sheet" April 29, p. 6). At an April 25 meeting with wholesalers, Marion Merrell Dow U.S. Prescription Products Division President David Roche said the firm will be "ready to ship within 11 days of approved labeling." He added that "our goal is to achieve 90% distribution in 80% of your key wholesale accounts within 10 days of that [shipment(BRACKET)." Marion expects that Seldane-D can generate $ 140 mil. in sales in its first year on the U.S. market. The combination product will have an initial advertising and promotion budget of $ 20 mil. The company plans to put 1,100 sales reps behind the launch of Seldane-D. Marion Merrell Dow expects to re-file its application for OTC marketing of terfenadine (Seldane) by the end of this year. The company withdrew the application to address concerns about the antihistamine's cardiovascular side effects. The concerns were raised by FDA's Pulmonary-Allergy Drugs Advisory Committee in June 1990 ("The Pink Sheet" June 18, 1990, T&G-1). The resubmission will contain the results of a clinical study involving Seldane use by individuals with impaired cardiovascular function.

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