Loading...
Loading...
AstraZeneca
AZN today announced that it has filed a lawsuit against the US Food and Drug Administration (FDA) in the US District Court for the District of Columbia to overturn the FDA's denial on March 7, 2012 of the company's Citizen Petitions with regard to SEROQUEL® (quetiapine fumarate) tablets and SEROQUEL XR® (quetiapine fumarate) extended release tablets.
In the Citizen Petitions, AstraZeneca raised important issues regarding labeling requirements for generic copies of innovative medicines, as well as data exclusivity rights granted to innovative companies that conduct new clinical trials.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in