Alphapharm Pty Ltd. v. Thompson
District Court, District of Columbia
1Opinion of the Court
MEMORANDUM
ROBERTSON, District Judge.
Plaintiff Mphapharm Pty Limited challenges the Food and Drug Administration’s (“FDA”) refusal to list the ’884 patent for citalopram (brand name Celexa®) in its Orange Book and FDA’s related refusal to receive Mphapharm’s abbreviated new drug application (“ANDA”) for review. Before the Court are the parties’ cross-motions for summary judgment. For the reasons stated below, defendant’s motion must be granted, plaintiffs cross-motion denied, and the case dismissed.
Background
The Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., prohib its the…
2Cases cited6 opinions
- Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
- Amer Bioscience Inc v. Thompson, Tommy G.Court of Appeals for the D.C. Circuit · 2001
- Valley Drug Co. v. Geneva Pharmaceuticals, Inc.Court of Appeals for the Eleventh Circuit · 2003
- Apotex, Inc. v. ThompsonCourt of Appeals for the Federal Circuit · 2003
- aaiPharma Inc. v. ThompsonCourt of Appeals for the Fourth Circuit · 2002
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