Legal Opinion

Mead Johnson Pharmaceutical Group v. Bowen

District Court, District of Columbia

Decided February 5, 1986No. Civ. A. 85-3971PublishedCited by 12 opinions

1Opinion of the Court

MEMORANDUM OPINION

NORMA HOLLOWAY JOHNSON, District Judge.

Plaintiff brings this action seeking a declaration that its drug product Desyrel, tra-zadone HCL, was approved for marketing by the Food and Drug Administration (FDA) in 1982 and not on December 24, 1981, the date of the FDA approval letter. Plaintiff seeks such a determination to qualify its product for a ten-year period of non-patent marketing exclusivity provided by the 1984 Amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. § 321, et seq. Plaintiff also requests injunctive relief prohibiting FDA from granting…

2Cases cited2 opinions

  1. Washington Metropolitan Area Transit Commission v. Holiday Tours, Inc.Court of Appeals for the D.C. Circuit · 1977
  2. Virginia Petroleum Jobbers Association v. Federal Power Commission, Blue Ridge Gas Company, Intervenor. Petition for Review of Order of the Federal Power Commission, No. 14583. Virginia Petroleum Jobbers Association v. Federal Power Commission, Appeal From United States District Court for the District of ColumbiaCourt of Appeals for the D.C. Circuit · 1958

3Cited by12 opinions

  1. Mylan Pharmaceuticals, Inc. v. ShalalaDistrict Court, District of Columbia · 2000
  2. Mead Johnson Pharmaceutical Group, Mead Johnson & Company v. Otis R. Bowen, Secretary of H.H.S.Court of Appeals for the D.C. Circuit · 1988
  3. Bristol-Myers Squibb Co. v. ShalalaDistrict Court, District of Columbia · 1996
  4. Varicon International v. Office of Personnel ManagementDistrict Court, District of Columbia · 1996
  5. Mylan Pharmaceuticals, Inc. v. HenneyDistrict Court, District of Columbia · 2000

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