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FDA approves generic Seroquel XR tablets
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Pharmadax Inc. recently announced that the FDA approved a generic version of Seroquel XR tablets for schizophrenia and specific symptoms in bipolar disorder and depression.
The approval includes 50 mg, 150 mg, 200 mg, 300 mg and 400 mg of quetiapine fumarate.
Seroquel XR is a once-daily tablet approved 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 as an adjunctive treatment with antidepressants for major depressive disorder.
“We are very excited to receive approval of our first controlled-release product, and second overall approval by the FDA. Launching this product in the U.S. market is a major milestone for Pharmadax,” Yipin Huang, MS, chairman of Pharmadax Inc., said in a press release. “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.”