Industry Briefs

FDA Approves Aripiprazole Generic

Last week the Food and Drug Administration (FDA) approved a generic version of aripiprazole intended to treat schizophrenia and bipolar disorder (manic depression). The approval is for the tablets in the strengths of 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg. The newly approved generic will be manufactured by Aurobindo Pharma.

Novartis Issues Recall on 10K Bottles of ADHD Medication

Novartis has issued a voluntary recall on 10,000 bottles of the attention-deficit/hyperactivity disorder medication dexmethylphenidate HCl-extended release manufactured by Alkermes in Gainsville, Ga. According to an FDA report, the product is being recalled due to an “out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.” The recall includes the 100-tablet bottles from lot number F0002 with an expiration date of December 2016.