Legal Opinion
Andrx Pharmaceuticals, Inc. v. Biovail Corp.
Court of Appeals for the Federal Circuit
Decided January 17, 2002No. Nos. 01-1650, 02-1025PublishedCited by 11 opinions
1Opinion of the Court
DYK, Circuit Judge.
Biovail Corporation (“Biovail”) appeals an order of the United States District Court for the Southern District of Florida. Pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), the district court (1) shortened the statutory thirty-month delay of approval of Andrx Pharmaceuticals, Inc.’s (“Andrx”) pending Abbreviated New Drug Application (“ANDA”) by the Food and Drug Administration (“FDA”) and (2) ordered that the ANDA be approved by the FDA. Andrx Pharms., Inc. v. Biovail Corp., 175 F.Supp.2d 1362 (S.D.Fla.2001). We hold that the district court exceeded its authority under 21 U.S.C. §…
2Cases cited15 opinions
- Anderson v. Liberty Lobby, Inc.Supreme Court of the United States · 1986
- Abbott Laboratories v. GardnerSupreme Court of the United States · 1967
- Amer Bioscience Inc v. Thompson, Tommy G.Court of Appeals for the D.C. Circuit · 2001
- Weinberger v. Hynson, Westcott & Dunning, Inc.Supreme Court of the United States · 1973
- Mova Pharmaceutical Corp. v. ShalalaCourt of Appeals for the D.C. Circuit · 1998
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3Cited by11 opinions
- Syntex (u.s.a.) LLC and Allergan, Inc. v. Apotex, Inc., Apotex Corp., and Novex PharmaCourt of Appeals for the Federal Circuit · 2005
- Minnesota Mining and Manufacturing Company and Riker Laboratories, Inc., and Alphapharm Pty. Ltd. v. Barr Laboratories, Inc.Court of Appeals for the Federal Circuit · 2002
- Swicegood v. Pliva, Inc.District Court, N.D. Georgia · 2008
- Dey, L.P. v. Ivax Pharmaceuticals, Inc.District Court, C.D. California · 2005
- Abbott Laboratories, Inc. v. Apotex Inc.District Court, N.D. Illinois · 2010
6 more not listed; retrieve them via the Exa API.