DR. REDDY'S LABORATORIES, INC., and Dr. Reddy'S Laboratories Ltd., Plaintiffs,
v.
Tommy G. THOMPSON, as Secretary of United States Department of Health and Human Services; Lester Crawford, as Acting Principal Deputy Commissioner of Food and Drugs, United States Food and Drug Administration; United States Food and Drug Administration; and Andrx Pharmaceuticals, Inc., Defendants,
v.
Genpharm, Inc., Intervenor-Defendant.
United States District Court, D. New Jersey.https://leagle.com/images/logo.png
September 15, 2003.
September 15, 2003.
Attorney(s) appearing for the Case
Budd, Larner, Rosenbaum, Greenberg & Sade, P.C., by Andrew J. Miller, Esq., Brian T. Moriarty, Esq., Vijayant Pawar, Esq., Short Hills, NJ, for Plaintiffs.
Robert D. McCallum, Jr., Assistant Attorney General, Christopher J. Christie, United States Attorney, by Susan Cassell, Asst. U.S. Attorney, United States Attorney's Office, Newark, NJ, Andrew E. Clark, Esq., Office of Consumer Litigation, U.S. Department of Justice, Washington, DC, Daniel E. Troy, Chief Counsel, Karen E. Schifter, Assoc. Chief Counsel, U.S. Food and Drug Administration, Rockville, MD, for the Government Defendants.
Proskauer Rose LLP, by Margaret A. Dale, Esq., Jennifer R. Scullion, Esq., Louis M. Solomon, Esq., Colin A. Underwood, Esq., New York, NY, Greenbaum, Rowe, Smith, Davis & Himmel LLP, by Richard L. Hertzberg, Esq., Woodbridge, NJ, for Defendant Andrx Pharmaceuticals, Inc.
Saiber, Schlesinger, Satz & Goldstein, LLC, by Arnold B. Calmann, Esq., Jeffrey Soos, Esq., Newark, NJ, Frommer, Lawrence & Haug LLP, by Edger H. Haug, Esq., Charles J. Raubicheck, Esq., Andrew M. Berdon, Esq., New York, NY, for Intervenor-Defendant Genpharm, Inc.
United States District Court, D. New Jersey.
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. Reddy's Laboratories Ltd. ("Reddy"...
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