FDA Broadens Caplyta Approval to Include Major Depression

FDA Broadens Caplyta Approval to Include Major Depression

(MedPage Today) -- The FDA approved lumateperone (Caplyta) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder in adults, Johnson & Johnson announced. Lumateperone was previously approved as an adjunctive...

FDA approves J&J’s antipsychotic drug to treat depression

Major depressive disorder is the fourth indication for the drug, and could help turn it into a blockbuster for Johnson & Johnson.

J&J brain drug acquired in $14.6B buyout cleared for broader use

Caplyta, which J&J got in its acquisition of Intra-Cellular Therapies, netted a clearance in major depressive disorder that’s key to achieving the $5 billion in annualized sales the company expects.

J&J’s Caplyta wins MDD approval to extend revenue horizon - Pharmaceutical Technology

Caplyta’s MDD label extension marks the first approval since J&J acquired the drug in a $14.6bn buyout.

FDA Approves Lumateperone as Adjunct Therapy for Major Depressive Disorder

FDA approves lumateperone as an adjunct therapy for major depressive disorder, offering new treatment options for this indication.

FDA Approves Lumateperone With Antidepressant Use for Major Depressive Disorder

As an adjunct to depression treatment, lumateperone reduced depressive symptoms and improved quality of life.