Monthly update of U.S. Food and Drug Administration (FDA) approvals impacting the workers' compensation industry. myMatrixx's report includes new drug and indication approvals, discontinuation and withdrawals, new dosages or formulations of existing products and newly available generics in the last 12 months.
Monthly Drug News
On Sept. 9, 2022, the FDA approved Zydus Pharmaceuticals’ cariprazine capsules, an AB-rated generic to AbbVie’s Vraylar®. The atypical antipsychotic is taken once each day to treat schizophrenia and bipolar I disorder. In a press release, Zydus indicated that it will share 180-day exclusivity for all four strengths of the capsules, but additional companies that will introduce generics to the U.S. market have not yet been identified. No launch date or cost are immediately available.
Impact to Workers’ Comp
Vraylar would most likely be utilized in workers’ compensation as an off-label adjunct to antidepressant therapy for use in major depressive disorder. For any questions about the use of Vraylar, depression medications, and potential relatedness to a claim, please consult with your myMatrixx pharmacist.