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Listing of Drug Product Information by Exclusivity Expiration - 2009

Range: 1 - 5

Applicant Tradename Generic Name NDA Approval Date Exclusivity Expiration Patented / Exclusive Use Sanofi Aventis Us KETEK telithromycin 021144 Apr 1, 2004 Apr 1, 2009 NEW CHEMICAL ENTITY Sanofi Aventis Us KETEK telithromycin 021144 Feb 9, 2005 Apr 1, 2009 NEW CHEMICAL ENTITY Novartis LESCOL fluvastatin sodium 020261 Dec 31, 1993 Apr 10, 2009 ADJUNCT TO DIET TO REDUCE TOTAL-C, LDL-C AND APO B LEVELS IN ADOLESCENT BOYS AND GIRLS WHO ARE AT LEAST ONE YEAR POST-MENARCHE, 10-16 YEARS OF AGE, WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA Novartis LESCOL XL fluvastatin sodium 021192 Oct 6, 2000 Apr 10, 2009 ADJUNCT TO DIET TO REDUCE TOTAL-C, LDL-C AND APO B LEVELS IN ADOLESCENT BOYS AND GIRLS WHO ARE AT LEAST ONE YEAR POST-MENARCHE, 10-16 YEARS OF AGE, WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA Novartis FOCALIN XR dexmethylphenidate hydrochloride 021802 Aug 1, 2006 Apr 11, 2009 REVISIONS TO CLINICAL STUDIES - CHILDREN AND ADOLSCENTS BASED ON CLINICAL TRIAL DATA TO SUPPORT A DURATION OF ACTION CLAIM UP TO 12 HOURS

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