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FDA Rejects Rhone-Poulenc’s Allergy Pill

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Bloomberg News

Rhone-Poulenc said its allergy pill ebastine was rejected by the Food and Drug Administration, dealing a blow to the company the French drug maker plans to create by merging with German rival Hoechst. Rhone-Poulenc had counted on ebastine to challenge Schering-Plough Corp.’s bestseller Claritin in the $3-billion allergy market. The FDA told Rhone-Poulenc its application “was not approvable on the basis of the information reviewed.” Rhone-Poulenc “will submit additional information to the FDA as quickly as possible,” said Karen Scott, a spokeswoman for Rhone-Poulenc Rorer Inc., the company’s U.S. unit. She declined to say why regulators turned down the drug and said the company hadn’t yet talked with FDA officials about the rejection. Ebastine is already sold in Europe, South America and Asia. Rhone-Poulenc’s American depositary receipts rose 94 cents to close at $45.94, while Hoechst’s ADRs fell $1.63 to $45.75, both on the NYSE.

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