Three generic versions of psychiatric drug launched
NEW YORK — Three companies have launched generic versions of a psychiatric drug made by AstraZeneca following a court decision turning down the Anglo-Swedish drug maker's request for an injunction against the Food and Drug Administration's approval of the generics.
Dr. Reddy's Labs, Teva and Mylan announced Wednesday the launch of their respective versions of quetiapine fumarate tablets, generic formulations of AstraZeneca's Seroquel, in strengths ranging from 25 mg to 400 mg.
The drug is used to treat schizophrenia, bipolar disorder and depression. The branded version had sales of $4.6 billion in 2011, according to IMS Health.
On Monday, the U.S. District Court for the District of Columbia dismissed AstraZeneca's lawsuit against the FDA. In September 2011, the drug maker had asked the FDA to withhold approval of generic versions of the drug whose labeling didn't include warnings about risks of elevated blood sugar and suicide that the agency had required AstraZeneca to include, but the FDA declined, prompting the company to file suit.