Hoechst Gain US Allergy Drug Approval

Hoechst Marion Roussel, the health care division of Hoechst, has received US Food and Drug Administration approval to market its nonsedating antihistamine, Allegra (fexofenadine hydrochloride). The company plans to price Allegra at 10%-15% per day less than Schering-Plough's Claritin (loratadine), based on wholesale price.

Allegra is indicated for the relief of seasonal allergic rhinitis and will be available from mid-to-late August on prescription only. Its active ingredient fexofenadine is a metabolite of terfenadine, the main component of Hoechst Marion Roussel's (formerly Marion Merrell Dow) Seldane. However, because of potential side effects including cardiovascular effects and interactions with antifungals and certain antibiotic drugs (Marketletters passim), US sales of Seldane have fallen from a peak of $600 million per year to around $400 million in 1995.

Fexofenadine, a New Chemical Entity, is expected to be an excellent treatment option, said Peter Ladell, president of Hoechst Marion Roussel, North America. It was developed and submitted for approval in only three years as opposed to the standard 14 years.