The first generic formulations of the atypical antipsychotic olanzapine have been approved by the Food and Drug Administration, the agency announced Oct. 24.
The new approvals are for olanzapine tablets and olanzapine orally disintegrating tablets.
Marketed as Zyprexa, olanzapine was first approved in 1996. It is indicated for the treatment of schizophrenia and bipolar I disorder. Like the trade version of the drug, generic olanzapine prescriptions must be dispensed with a medication guide for patients that describes the risks and adverse effects associate with the drug, which are also included in the drug’s label, the statement said.
A boxed warning on the label states that treatment with antipsychotic drugs increases the risk of death in elderly patients with dementia-related psychosis, and that olanzapine is not approved for treating patients with dementia-related psychosis, according to the FDA.
The FDA statement also refers to the serious risks associated with olanzapine, which include weight gain, hyperglycemia, and increased cholesterol and triglycerides. In addition, the statement says that "clinicians should take these effects into account when deciding to use this type of medication."
The manufacturers of generic olanzapine tablets are Dr. Reddy’s Laboratories and Teva Pharmaceuticals USA. The manufacturers of generic forms of olanzapine orally disintegrating tablets are Apotex, Dr. Reddy’s, and Par Pharmaceuticals, according to the FDA’s statement.
Olanzapine is the third atypical antipsychotic to become available in generic formulations. Clozapine was the first, followed by risperidone, according to an FDA spokesperson.