Industry Briefs

FDA Approves Austedo for Treatment of Tardive Dyskinesia

Teva Pharmaceuticals Ltd. last week announced that the Food and Drug Administration has approved Austedo (deutetrabenazine) tablets for the treatment of adults with tardive dyskinesia (TD). Deutetrabenazine is a small molecule vesicular monoamine 2 transporter (VMAT2) inhibitor that has FDA approval for the treatment of chorea associated with Huntington’s disease.

The approval was based in part on the results of two 12-week, randomized, double-blind, placebo-controlled, multicenter trials, which compared changes in involuntary movements in 335 patients with TD who took deutetrabenazine or placebo.

In both trials, patients taking deutetrabenazine (24 mg/day to 48 mg/day) experienced statistically significant improvement in their Abnormal Involuntary Movement Scale (AIMS) score, from baseline to week 12, compared with placebo.

Amneal Recalls 13 Lots of Oral Lorazepam Due to Dropper Defects

Amneal Pharmaceuticals is voluntarily recalling 13 lots of lorazepam oral concentrate (2 mg/mL) from market due to a defect in the dosing droppers.

The company stated that there is no issue with the medication itself, but some of the droppers in the affected lots have marking errors. These errors include dose markings printed in reverse number order, dose markings that are shifted, or no dose markings at all.

These errors increase the risk that individuals may dispense more or less than their prescribed dose, which can lead to adverse effects including drowsiness, increased anxiety, and/or accidental injury to self or others.

In a press release, Amneal described how the company had issued recall letters and replacement droppers to all pharmacies that may have received the defective lots. A list of the 13 recalled lots can be found here. ■