Thursday, March 29, 2012

FDA Law Blog: AstraZeneca Loses TRO Bid in Second Generic SEROQUEL Lawsuit


By Kurt R. Karst –

In litigation that moved at breakneck speed on March 28, 2012, Judge Beryl A. Howell of the U.S. District Court for the District of Columbia denied AstraZeneca Pharmaceuticals LP’s (“AstraZeneca’s”) Motion for Temporary Restraining Order (Complaint here) seeking to vacate FDA’s March 27, 2012 approval of more than 10 ANDAs for generic versions of AstraZeneca’s blockbuster antipsychotic drug SEROQUEL (quetiapine fumarate) Tablets (NDA No. 020639), and to enjoin FDA from granting any further final ANDA approvals for the drug until the court decides the case on the merits.

Posted via email from Jack's posterous

No comments: