Monday, March 23, 2009

FDA approves antidepressant Lexapro for adolescents

The decision comes after Justice Department allegations that the drug's maker, Forest Laboratories, had improperly induced pediatricians to prescribe it and a similar pill, Celexa.

Just weeks after prosecutors accused Forest Laboratories Inc. of illegally marketing its antidepressants Celexa and Lexapro to children and paying pediatricians kickbacks, U.S. health regulators Friday approved Lexapro for depression in kids.

Forest said Lexapro was approved by the U.S. Food and Drug Administration to treat major depressive disorder in adolescents aged 12 to 17 and as a maintenance therapy to control symptoms. It is already approved for adults, and registers annual sales of more than $2 billion.

The FDA on Friday approved Lexapro's use for adolescents based on favorable results in two clinical trials -- one involving adolescents taking Lexapro and another involving children and adolescents taking the chemically similar Celexa, Forest said.


No comments: