US court turns down AstraZeneca FDA injunction; Teva debuts generic Seroquel in UK

In another setback for Anglo-Swedish drug major AstraZeneca in its fight to delay generic competition for its blockbuster antipsychotic Seroquel (quetiapine), the US District Court for the District of Columbia late last Friday issued an opinion and order in the law suit against the US Food and Drug Administration regarding final marketing approval of generic quetiapine.

In a 33-page decision, Judge Colleen Kollar-Kotelly denied the company’s request for a preliminary injunction and dismissed the lawsuit without prejudice. Considering the record as a whole, Judge Kollar-Kotelly concluded that AstraZeneca failed to make the clear showing necessary to grant a preliminary injunction, and that each of the four factors a court considers in deciding whether or not to grant preliminary injunctive relief did not weigh in AstraZeneca’s favor, noted Kurt Karst of US law firm Hyman, Phelps and McNamara.

While Judge Kollar-Kotelly noted that AstraZeneca might want to seek judicial intervention in an expedited proceeding if and when the FDA grants final ANDA approval, she commented that “any concern in this regard is ameliorated somewhat by the fact that the FDA has already voluntarily bound itself to provide AstraZeneca with advance notice of its intention to issue a final decision adverse to AstraZeneca and represents that it will consent to expedited briefing in the event preliminary relief is sought in the future,” commented Mr Karst on the law firm’s FDA Law Blog.