Legal Opinion
Dr. Reddy's Laboratories, Inc. v. Thompson
District Court, D. New Jersey
Decided September 15, 2003No. Civil 02-452(WGB)PublishedCited by 12 opinions
1Opinion of the Court
AMENDED OPINION
BASSLER, District Judge.
This is an action pursuant to the Administrative Procedure Act (APA), 5 U.S.C. § 701, et seq., challenging decisions made by the Food and Drug Administration (FDA) during the generic drug approval process for one of several generic versions of omeprazole, a drug consumers know by the brand name Prilosec®. Plaintiffs Dr. Reddy’s Laboratories, Inc., and Dr. Red-dy’s Laboratories Ltd. (“Reddy”) challenge the legality of certain aspects of the FDA’s interpretation of the Drug Price Competition and Patent Term Restoration Act of 1994. Hatch-Waxman Act, Pub.L.…
2Cases cited33 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
- Abbott Laboratories v. GardnerSupreme Court of the United States · 1967
- Skidmore v. Swift & Co.Supreme Court of the United States · 1944
- United States v. Mead Corp.Supreme Court of the United States · 2001
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3Cited by12 opinions
- Hi-Tech Pharmacal Co. v. United States Food & Drug AdministrationDistrict Court, District of Columbia · 2008
- Ranbaxy Labs Ltd v. Leavitt, Michael O.Court of Appeals for the D.C. Circuit · 2006
- Apotex Inc. v. Food & Drug AdministrationDistrict Court, District of Columbia · 2006
- Teva Pharmaceuticals, Industries, Ltd. v. Food & Drug AdministrationDistrict Court, District of Columbia · 2004
- Apotex, Inc. v. Daiichi Sankyo, Inc.Court of Appeals for the Federal Circuit · 2015
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