Legal Opinion
Apotex Inc. v. Food & Drug Administration
District Court, District of Columbia
Decided February 13, 2006No. CIV.A. 05-0125(JDB)PublishedCited by 11 opinions
1Opinion of the Court
MEMORANDUM OPINION
BATES, District Judge.
Plaintiff Apotex, Inc. (“Apotex”) brings this action against the Food and Drug Administration (“FDA”), Secretary of Health and Human Services Michael O. Leavitt, and Acting FDA Commissioner Lester M. Crawford, challenging FDA’s decision to deny immediate approval to Apotex for a generic version of the drug omeprazole as arbitrary and capricious under the Administrative Procedure Act (“APA”), 5 U.S.C. § 706(2). In essence, the parties disagree regarding the proper interpretation of 21 U.S.C. § 355(j)(5)(B)(iv) (2000), 1 the same statutory provision at…
2Cases cited28 opinions
- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- Citizens to Preserve Overton Park, Inc. v. VolpeSupreme Court of the United States · 1971
- Landgraf v. USI Film ProductsSupreme Court of the United States · 1994
- United States v. Mead Corp.Supreme Court of the United States · 2001
- Robinson v. Shell Oil Co.Supreme Court of the United States · 1997
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3Cited by11 opinions
- Hi-Tech Pharmacal Co. v. United States Food & Drug AdministrationDistrict Court, District of Columbia · 2008
- National Association for Home Care & Hospice, Inc. v. SebeliusDistrict Court, District of Columbia · 2015
- Council for Urological Interests v. SebeliusDistrict Court, District of Columbia · 2013
- National Automobile Dealers Association v. Federal Trade CommissionDistrict Court, District of Columbia · 2012
- Teva Pharm. United States, Inc. v. AzarCourt of Appeals for the D.C. Circuit · 2019
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