First Versions of Generic Zyprexa Approved
MONDAY Oct. 24, 2011 -- The first generic versions of Zyprexa (olanzapine) have been approved by the U.S. Food and Drug Administration to treat schizophrenia or bipolar disorder, the agency said Monday.
Olanzapine has a boxed label warning that the drug can cause death among elderly people who have psychosis due to confusion and memory loss, the FDA said in a news release. Other serious adverse reactions could include high blood sugar, high cholesterol or triglycerides, and weight gain.
Schizophrenia is a brain disorder that affects about 1 percent of Americans, with symptoms including hearing voices, paranoia, being suspicious and withdrawing from everyday life. Bipolar disorder, also known as manic-depressive illness, includes symptoms such as unusual changes in mood, energy and ability to perform daily tasks.
The agency said any generic drugs it approves are clinically equivalent to the brand-name versions in quality, strength, purity and stability.
Approval to produce generic versions of olanzapine were given to: Dr. Reddy's Laboratories Ltd., Teva Pharmaceuticals USA, Apotex Inc. and Par Phamaceuticals Inc.
The FDA has more about Zyprexa.
Posted: October 2011