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JEROME STEVENS PHARMACEUT. v. FOOD & DRUG ADMIN.

No. 04-5238.

402 F.3d 1249 (2005)

JEROME STEVENS PHARMACEUTICALS, INC., Appellant v. FOOD & DRUG ADMINISTRATION, et al., Appellees

United States Court of Appeals, District of Columbia Circuit.

Decided April 8, 2005.

Attorney(s) appearing for the Case

Samuel H. Israel argued the cause for appellant. With him on the briefs were John P. Halfpenny and Russell J. Gaspar.

Thomas M. Bondy, Attorney, U.S. Department of Justice, argued the cause for appellees. With him on the brief were Peter D. Keisler, Assistant Attorney General, Kenneth L. Wainstein, U.S. Attorney, and Mark B. Stern, Attorney.

Before: SENTELLE, HENDERSON and ROGERS, Circuit Judges.

ROGERS, Circuit Judge.

The Food and Drug Administration ("FDA") posted on its website trade secrets and confidential information contained in a New Drug Application ("NDA") filed by Jerome Stevens Pharmaceuticals, Inc. ("JSP") for Unithroid, a levothyroxine sodium ("LS") drug used to treat thyroid diseases. FDA also extended the NDA approval deadline, allowing JSP's competitors to continue marketing their unapproved LS drugs for three years after Unithroid had been...

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