Industry Briefs

Vraylar Now Available In United States

Allergan plc announced this week that Vraylar (cariprazine)is now available by prescription in pharmacies throughout the United States.

Vraylar, an oral, once-daily atypical antipsychotic, was approved by the Food and Drug Administration (FDA) in September 2015 for the treatment of acute manic or mixed episodes of bipolar I disorder and schizophrenia in adults after it was shown to significantly improve total scores on the Young Mania Rating Scale in patients with bipolar I disorder in three 3-week controlled trials and total scores on the Positive and Negative Syndrome Scale in patients with schizophrenia in three 6-week controlled trials.

Vraylar is available in 30-count bottles in 1.5 mg, 3 mg, 4.5 mg, and 6 mg strengths as well as a seven-count mixed blister pack (one 1.5 mg and six 3 mg capsules).

Zydus Pharmaceuticals Recalls Risperidone Tablets

Zydus Pharmaceuticals USA Inc. is voluntarily recalling 9,504 bottles of risperidone orally disintegrating tablets made in India by the company’s subsidiary firm Cadila Healthcare, the FDA announced this month in an Enforcement Report.

The recall was designated a Class III by the FDA. This classification, according to the FDA, is issued when the product is unlikely to cause any adverse health reaction but violates FDA labelling or manufacturing laws. ■