The FDA has given the nod to Abbott's Depakote ER (divalproex sodium) tablets for the treatment of mania or mixed episodes with or without psychotic features associated with bipolar disorder. Depakote ER is the once-daily formulation of Depakote tablets, which has been a treatment for bipolar disorder since its approval in 1995.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.