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FDAnews Drug Daily Bulletin
Oct. 8, 2012 | Vol. 9 No. 197
Apotex Lawsuit: FDA Wrongly Holding Up ANDA Approvals Because of Lost Inspection Report
Apotex is taking the FDA to court for failing to grant timely approval of its ANDAs for two Sanofi hypertension treatments, Avapro and Avalide. The Office of Generic Drugs (OGD) has yet to approve the ANDAs because the agency’s Office of Compliance cannot locate an inspection report it should have long ago created and reviewed, the Canadian generic-drug maker says.
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