FDA denies terfenadine stay of ANDA approval petitions from Marion Merrell Dow and Geneva.
FDA DENIES GENERIC TERFENADINE ANDA STAY OF APPROVAL PETITIONS by Marion Merrell Dow and Ciba's Geneva generics operations for generic versions of the antihistamine Seldane. MMD and Geneva filed petitions in April and July, respectively, requesting that FDA refrain from approving any new or pending ANDAs containing terfenadine and require all ANDAs to certify to a patent covering Seldane, dating from September 1993.
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