Florida Breckenridge, Inc. v. Solvay Pharmaceuticals, Inc., 98-4606
Decision Date | 11 May 1999 |
Docket Number | No. 98-4606,98-4606 |
Parties | 1999-1 Trade Cases P 72,519, 50 U.S.P.Q.2d 1761, 12 Fla. L. Weekly Fed. C 853 FLORIDA BRECKENRIDGE, INC. d.b.a. Breckenridge Pharmaceutical, Inc., Plaintiff-Counterclaim-Defendant-Appellee, v. SOLVAY PHARMACEUTICALS, INC., a Georgia corporation, Defendant-Counterclaim-Plaintiff-Appellant, |
Court | U.S. Court of Appeals — Eleventh Circuit |
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Healthpoint, Ltd. v. Ethex Corp.
...that Accuzyme is not marketed lawfully, Ethex would be required to withdraw Ethezyme as well. Ethex argues that the FDA's position in the Solvay brief is entitled to no deference from the Court, but if it is considered, Accuzyme cannot meet the test for the GRAS/E or grandfather exceptions ......
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Healthpoint, Ltd. v. Stratus Pharmaceuticals, Inc.
...in the FDA's regulations, the Orange Book, and encompassed by CDER's definition of "generic." As urged by the FDA in its amicus brief in Solvay, to allow a drug manufacturer to use the word "generic" to mean something different for unapproved and approved drugs will confuse the Although the......
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Migdalia M v. Saul
..., 313 Fed.Appx. 851, 853 (7th Cir. 2009) ; U.S. v. Kozinski , 16 F.3d 795, 811 (7th Cir. 1994) ; Florida Breckenridge, Inc. v. Solvay Pharm., Inc. , 174 F.3d 1227, 1233-34 (11th Cir. 1999).Plaintiff also claims she required a crutch for ambulation for months [Dkt. # 16, at 10], but of cours......
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U.S. v. Sage Pharmaceuticals, 99-30425
...a notice was published in the federal register and a supplemental NDA was approved for the drug. Florida Breckenridge, Inc. v. Solvay Pharmaceuticals, Inc., 174 F.3d 1227, 1229 (11th Cir. 1999), withdrawn at the request of the The DESI program was the basis for a short-lived policy under wh......
1 books & journal articles
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Tell the truth.
...re Disciplinary Action Boucher, 837 F.2d 869, 871 (9th Cir. 1988). (20) See Florida Breckenridge, Inc. v. Solvay Pharmaceuticals, Inc., 174 F.3d 1227 (11th Cir. 1999) (opinion withdrawn from bound volume at court's request). (21) Id. at * 7. (22) 174 F.3d at * 8. (23) Arizonans for Official......