FDA Approves Oxford Pharm Generic Simvastatin Tablets (ANDA078735)

The U.S. Food and Drug Administration has granted approval for an abbreviated new drug application (ANDA) identified as ANDA078735, submitted by Oxford Pharm. The approval encompasses five oral tablet products containing the active ingredient simvastatin at strengths of 5 mg, 10 mg, 20 mg, 40 mg and 80 mg. All products are designated for prescription use and are not listed as reference drugs or reference standards. The original submission (submission number 1) received an approved status on August 30, 2010. Additional FDA documentation related to this submission is available online (http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm).