FDA Approves ANDA 076768 for Alendronate Sodium Tablets

The U.S. Food and Drug Administration has approved an Abbreviated New Drug Application (ANDA) numbered 076768 for alendronate sodium tablets. The approval encompasses oral prescription tablets produced by Exelan Pharmaceuticals Inc. and Cipla USA Inc., available in strengths of 5 mg, 10 mg, 35 mg, 40 mg and 70 mg (equivalent base). Labeling submissions for this ANDA received FDA approval on August 4 2008 (original), July 7 2011 and February 12 2016, indicating updates to product labeling over time. These products are listed under the brand name Alendronate Sodium and are classified as human prescription drugs.