Mylan receives final FDA approval for generic Zyprexa ANDA

Apr 25 2012

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Olanzapine Tablets USP, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg. This product is the generic version of Eli Lilly and Company's Zyprexa®, which is indicated for the treatment of schizophrenia and the acute treatment of manic or mixed episodes associated with bipolar 1 disorder and maintenance treatment of bipolar 1 disorder.

Olanzapine Tablets USP, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg, had U.S. sales of approximately $3.3 billion for the 12 months ending Dec. 31, 2011, according to IMS Health. Mylan is shipping this product immediately.

Currently, Mylan has 171 ANDAs pending FDA approval representing $97.2 billion in annual sales, according to IMS Health. Forty of these pending ANDAs are potential first-to-file opportunities, representing $25.7 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.