March 28, 2012
/PRNewswire/ -- 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
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
in annual sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing
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. For more information about Mylan, please visit
. For more information about generic drugs, please visit
 Atypical antipsychotic medications have been associated with an increased risk of death in elderly patients with dementia-related psychosis and patients with dementia-related psychosis should not take quetiapine fumarate. There is also an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorders and other psychiatric disorders. Other risks associated with quetiapine fumarate include but are not limited to neuroleptic malignant syndrome, diabetes mellitus, increased cholesterol and triglycerides, weight gain, increases and decreases in blood pressure, changes in blood counts, changes in ECGs and the formation of cataracts.