Pharmadax receives FDA approval for a generic version of Seroquel XR®.
Pharmadax Inc., a pharmaceutical company based in New Taipei City, Taiwan, and its subsidiary Pharmadax USA, Inc., based in Irvine, California, 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.”
(Source: PR Newswire)