FDA

Introduction

Indication is an illness or condition for which a drug or device is helpful, or "indicated." The Food and Drug Administration (FDA) classifies indications for drugs in the United States. Indications for drugs can be classified in two categories:

• FDA-approved, also called labeled indications
• Non FDA-approved, also called off-label indications

Bipolar Disorder in Adults

FDA Approval	Acute Mania (alone)	Acute Mania (w Li+ or VPA)	Acute Depression	Maintenance Alone	Maintenance w Li+ or VPA
Li+	+			+
Carbamazepine	+			+
Lamotrigine				+	+ with VPA
Valproic Acid	+	+
Seroquel	+	+	+		+
Zyprexa	+	+		+
Risperdone	+	+		+
Abilify, Geodon	+		+
Zyprexa + Prozac (Symbyax)			+