Seroquel XR Gets MDD Nod and CRL

AZ's Seroquel XR gets adjunctive MDD indication, but also response letter for other sNDAs

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has approved AstraZeneca‘s once-daily Seroquel XR Extended Release Tablets as an adjunctive treatment to antidepressants in adults with Major Depressive Disorder (MDD). Seroquel XR is the only medication in its class approved by the FDA to treat both MDD as adjunctive therapy and acute depressive episodes associated with bipolar disorder as monotherapy, according to AZ. MDD affects approximately 14.2 million American adults in a given year, and is often treated with antidepressa...

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