Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Eli Lilly and Company's ZYPREXA(R) Zydis(R) (Olanzapine) Orally Disintegrating Tablets, 5mg, 10mg, 15mg and 20mg. The Company anticipates receiving final approval following the expiration of the 30-month stay in April 2007.
There is currently a disagreement between Barr and Eli Lilly regarding the length of the patent on Zyprexa - and whether Barr is ultimately allowed to sell the generic drug has yet to be decided.
ZYPREXA (olanzapine) is indicated for the treatment of schizophrenia and for the short-term treatment of acute manic episodes associated with Bipolar I disorder.
A tentative approval reflects FDA's preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of all statutorily imposed non-approval periods. A tentative approval does not allow the applicant to market the generic drug product.