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BURROUGHS WELLCOME CO. v. BOWEN

No. 86-173-CIV-5.

630 F.Supp. 787 (1986)

BURROUGHS WELLCOME COMPANY, Plaintiff, v. Otis BOWEN, in his capacity as Secretary of Health and Human Services, et al., Defendants.

United States District Court, E.D. North Carolina, Raleigh Division.

February 28, 1986.

Attorney(s) appearing for the Case

Michael E. Weddington, Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, Raleigh, N.C., Richard S. Morey, Kleinfeld, Kaplan & Becker, Washington, D.C., for Burroughs Wellcome Co.

Samuel T. Currin, U.S. Atty., Raleigh, N.C., Lawrence G. McDade, Dept. of Justice, Office of Consumer Litigation, Washington, D.C., for Bowen and Young.

Robert W. Spearman, Sanford, Adams, McCullough & Beard, Raleigh, N.C., Joel E. Hoffman, Sutherland, Asbill & Brennan, Washington, D.C., for Lederle Laboratories.

ORDER

BRITT, Chief Judge.

In this action Burroughs Wellcome Company (Burroughs) asks the court to overturn a new drug application (NDA) approval issued 30 January 1986 by the Food and Drug Administration (FDA) for an oral leucovorin calcium product manufactured by Lederle Laboratories (Lederle). Leucovorin calcium is used as an antidote to the adverse effects of chemotherapeutic drugs and other medications. On...

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