FDA Approves ANDA077766 for Simvastatin Generic Tablets

The U.S. Food and Drug Administration has approved Abbreviated New Drug Application (ANDA) number 077766 submitted by Chartwell Rx. The application encompasses five oral tablet products of the generic drug Simvastatin, available in strengths of 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg. All five products are recorded with a marketing status of "Discontinued" and are not designated as reference drugs or reference standards. Each product is identified by a unique product number ranging from 001 to 005. The original submission (submission #1, type ORIG) received approval on 20 December 2006. Subsequent supplemental submissions (#2 on 10 July 2007, #3 on 19 October 2012, #4 on 28 December 2015, and #5 on 28 December 2015) were approved for labeling changes, each with a standard review priority. The FDA posting includes an additional document linked at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm, dated 26 May 2011.