US court denies preliminary injunction application against the FDA
Posted: 26 March 2012 | | 1 comment
The US District Court for the District of Columbia issued an opinion and order in AstraZeneca’s lawsuit…
On 23 March 2012, the US District Court for the District of Columbia issued an opinion and order in AstraZeneca’s lawsuit against the US Food and Drug Administration (FDA) regarding final marketing approval of generic quetiapine. The Court denied the company’s request for a preliminary injunction and dismissed the lawsuit without prejudice.
Notwithstanding the Court’s decision, the company continues to believe strongly in the merits of its position and is evaluating its options.
What was the reason for denial of approval in the first place?