FDA actions in brief, January 2010 (Cymbalta, Zyprexa, Zyprexa Relprevv, Intelence, Kalbitor, Istodax, Geodon, Vagifem, Seroquel XR, Clonidine ER Suspension, Clonidine ER Tablets, Wilate)

Duloxetine HCl (Cymbalta, Eli Lilly) was approved for the maintenance treatment of generalized anxiety disorder in adults.

Olanzapine (Zyprexa, Eli Lilly) was approved as treatment for schizophrenia and bipolar disorder in teenagers.

Olanzapine extended release injectable suspension (Zyprexa Relprevv, Eli Lilly) was approved for the treatment of schizophrenia in adults.

Ecallantide (Kalbitor, Dyax) was approved for treatment of hereditary angioedema in patients 16 years and older.

Romidepsin (Istodax, Gloucester Pharmaceuticals) was approved for the treatment of cutaneous T-cell lymphoma in patients who have received at least one prior systemic therapy.

Ziprasidone (Geodon, Pfizer) was approved for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate.

Estradiol vaginal tablets, 10 µg dose formulation (Vagifem, Novo Nordisk) for the treatment of atrophic vaginitis due to menopause.

Quetiapine fumarate extended-release tablets (Seroquel XR, AstraZeneca) as an add-on for antidepressants used by adults with major depressive disorder.

Direct-acting alpha 2 adrenergic agonists in two different strengths (once-daily Clonidine ER Suspension and once-daily Clonidine ER Tablets, Tris Pharma) were approved for treatment of hypertension.

Double virus inactivated von Willebrand factor/coagulation factor VIII concentrate, human (Wilate, Octapharma USA), was approved for the treatment of spontaneous and trauma-induced bleeding episodes in patients with all types of von Willebrand disease.