Pharmadax Receives FDA Approval for a Generic Version of Seroquel XR®
Wednesday, May 17, 2017
Pharmadax Inc., a pharmaceutical company based in New Taipei City, Taiwan, and its subsidiary Pharmadax USA, Inc., based in Irvine, California, today announced that 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. Pharmadax has launched the product with their Marketing Partner, TruPharma LLC.
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.
Yipin Huang, Chairman of Pharmadax Inc., stated: "We are very excited to receive approval of our first controlled-release product, and second overall approval by the US FDA. 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."
