AstraZeneca Can't Get FDA Tip-Off On Generic Approvals

Law360, New York (March 26, 2012, 7:28 PM ET) -- AstraZeneca PLC on Monday unsuccessfully tried to force the U.S. Food and Drug Administration to notify it before approving a generic form of its antipsychotic drug Seroquel, two days after losing its bid to delay the approval of Seroquel generics with labels that omit hyperglycemia warnings.

A Washington federal judge on Friday dismissed AstraZeneca's suit seeking to delay until December the approval of generic versions of Seroquel with labels that omit hyperglycemia warnings that AstraZeneca was required to add. U.S. District Judge Colleen Kollar-Kotelly found that...
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Case Title

ASTRAZENECA PHARMACEUTICALS LP v. FOOD AND DRUG ADMINISTRATION et al


Case Number

1:12-cv-00388

Court

District Of Columbia

Nature of Suit

Other Statutory Actions

Judge

Colleen Kollar-Kotelly

Date Filed

March 12, 2012

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