FDA Approves Sanofi Aventis NDA012283 for HYGROTON Chlorthalidone Tablets

The U.S. Food and Drug Administration (FDA) has approved application NDA012283 submitted by Sanofi Aventis US. The submission, classified as a Type 1 New Molecular Entity and given priority review, received an approved status on April 7, 1960. The approved products are marketed under the brand name HYGROTON. Both are oral tablets: one containing 25 mg of chlorthalidone (product number 004) and the other containing 50 mg of chlorthalidone (product number 003). Although both products are listed with a marketing status of “Discontinued,” the Federal Register has determined that the discontinuation was not due to safety or effectiveness concerns. Key details: - Sponsor: Sanofi Aventis US - Application number: NDA012283 - Submission type: Original (ORIG), priority review - Product route: Oral - Dosage form: Tablet - Active ingredient: Chlorthalidone (25 mg and 50 mg)