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ASTRAZENECA PHARMACEUTICALS v. FOOD & DRUG ADMIN.

Civil Action No. 12-00388(CKK).

850 F.Supp.2d 230 (2012)

ASTRAZENECA PHARMACEUTICALS LP, Plaintiff, v. FOOD AND DRUG ADMINISTRATION, Margaret A. Hamburg, M.D., Commissioner of Food and Drugs, and Kathleen Sebelius, Secretary of Health and Human Services, Defendants.

United States District Court, District of Columbia.

March 23, 2012.

Attorney(s) appearing for the Case

Timothy C. Hester, Covington & Burling LLP, Benjamin C. Block, U.S. Commodity Futures Trading Commission, Washington, DC, for Plaintiff.

Gerald Cooper Kell, U.S. Department of Justice, Civil Division, Office of Consumer Litigation, Washington, DC, for Defendants.

MEMORANDUM OPINION

COLLEEN KOLLAR-KOTELLY, District Judge.

Plaintiff AstraZeneca Pharmaceuticals LP ("AstraZeneca") holds new drug applications for SEROQUEL® ("Seroquel") and SEROQUEL XR® ("Seroquel XR"), antipsychotic drugs used to treat serious psychological disorders such as schizophrenia. Since AstraZeneca first obtained approval to market these drugs in the United States from the Food and Drug Administration (the "FDA"), it has been free to...

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