Searle Calan SR/Knoll Isoptin SR
Executive Summary
Searle submits preliminary data to FDA from a study completed in September on the steady-state pharmacokinetics and pharmacodynamics of sustained-release verapamil. In Oct. 3 comments on Knoll's recommendations to FDA for verapamil SR bioequivalence studies, Searle said it will soon submit final results of the study to FDA. Searle is seeking a delay in the approval of ANDA suitability petitions for the sustained-release formulation until FDA has reviewed the results of the study. Exclusivity for sustained-release verapamil runs out on Dec. 16. At least two companies have submitted ANDA suitability petitions for verapamil SR -- Lederle, in July, for a 120 mg dosage form and Pioneer Pharmaceuticals, in September, for 120 mg and 180 mg dosage strengths.
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