Taiwan’s Pharmadax has received approval from the US Food and Drug Administration (FDA) to market a generic equivalent of the anti-psychotic drug Seroquel XR (quetiapine fumarate) at five different strengths.
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.
According to IMS Health data, US sales of Seroquel XR and generic equivalents for the five strengths to be sold by Pharmadax and its marketing partner, TruPharma, were approximately $1.34 billion in 2016. The original product was developed by Anglo-Swedish pharma major AstraZeneca (LSE: AZN).
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