FDA approves bipolar disorder generic


IRVINE, Calif. — The Food and Drug Administration has approved Pharmadax’s generic equivalent to AstraZeneca’s Seroquel XR (quetiapine fumarate) ER tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg. Pharmadax has launched the product with its marketing partner, TruPharma.

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.

"We are very excited to receive approval of our first controlled-release product, and second overall approval by the U.S. FDA,” said Yipin Huang, chairman of Pharmadax. “Launching this product in the U.S. 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.”

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


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