Mylan receives FDA approval for generic Seroquel ANDA

Mar 29 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 Quetiapine Fumarate Tablets, 25 mg. This product is the generic version of AstraZeneca's Seroquel®, which is an atypical antipsychotic medication indicated for the treatment of schizophrenia, and for the treatment of acute manic episodes associated with bipolar disorder.

Seroquel Tablets, 25 mg, had U.S. sales of approximately $568.4 million for the 12 months ending Dec. 31, 2011, according to IMS Health. Mylan is shipping this product immediately.

Currently, Mylan has 172 ANDAs pending FDA approval representing $99.9 billion in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $26.9 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies.