No. 77-1892.

587 F.2d 1173 (1978)

HOLLAND-RANTOS COMPANY, INC., Petitioner, v. UNITED STATES DEPARTMENT OF HEALTH, EDUCATION AND WELFARE, Joseph Califano, Secretary of Department of Health, Education and Welfare, Food and Drug Administration and Donald Kennedy, Commissioner of Food and Drug Administration, Respondents.

United States Court of Appeals, District of Columbia Circuit.

Decided July 17, 1978.

Attorney(s) appearing for the Case

F. Kaid Benfield, Washington, D. C. with whom, Charles H. Barr, Richland, Wash., was on the brief, for petitioner.

Patricia J. Kenney, Atty. for Dept. of Justice, Washington, D. C., with whom John H. Shenefield, Asst. Atty. Gen., Charles R. McConachie, Atty., Dept. of Justice, Washington, D. C., Richard M. Cooper, Chief Counsel, Rockville, Md., Eric M. Blumberg, Associate Chief Counsel for Enforcement for Food and Drug Administration, Washington, D. C.

Before BAZELON, LEVENTHAL and ROBINSON, Circuit Judges.



Holland-Rantos Co. petitions this court to set aside an order of the Commissioner of the Food and Drug Administration (FDA) denying a hearing and withdrawing approval from the new drug application (NDA) of Nylmerate Jelly. See 42 Fed.Reg. 49521 (1977). Petitioner argues that summary judgment is inappropriate because it has presented evidence of adequate and well-controlled investigations demonstrating the effectiveness...

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