SILVER SPRING, Md. — The Food and Drug Administration on Thursday approved Lupin’s generic of AstraZeneca’s Zeroquel XR (quetiapine fumarate) extended-release tablets.
The drug is indicated to treat schizophrenia, acute manic or mixed bipolar I disorder on its own or as an adjunctive treatment to lithium or divalproex, acute depressive disorders in bipolar disorder, maintenance treatment of bipolar I, as an adjunctive treatment to lithium or divalproex and as an adjunctive treatment to antidepressants for the treating major depressive disorder.
Lupin’s generic will be available in 50-, 150-, 200-, 300- and 400-mg dosage strengths. Seroquel XR had U.S. sales of $1.27 billion for the 12 months ended March 2017, according to QuintilesIMS data.