Pharmadax Receives FDA Approval for Generic Version of Seroquel XR

Pharmadax announced the U.S. Food and Drug Administration (FDA) has approved a generic equivalent to Seroquel XR (quetiapine fumarate) ER tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg.

Seroquel XR is a once-daily tablet indicated for the treatment of schizophrenia; acute depressive episodes in bipolar disorder; acute manic or mixed episodes in bipolar disorder alone or with lithium or divalproex; and adjunctive therapy to antidepressants for patients with major depressive disorder (MDD).

According to IMS Health data, U.S. sales of Seroquel XR and generic equivalents for the 5 strengths to be marketed by TruPharma LLC were approximately $1.34 billion for the 12 months ended December 31, 2016.

"We are very excited to receive approval of our first controlled-release product, and second overall approval by the US FDA," Yipin Huang, Chairman of Pharmadax said. "Launching this product in the US market is a major milestone for Pharmadax.  Leveraging on our unique business model and technology platform, we look forward to providing more affordable and high quality complex dosage forms to the American public."