Legal Opinion
Jerome Stevens Pharmaceuticals, Inc. v. Food & Drug Administration
Court of Appeals for the D.C. Circuit
Decided April 8, 2005No. 04-5238PublishedCited by 1,295 opinions
1Opinion of the Court
Opinion for the Court filed by Circuit Judge ROGERS.
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 approved. JSP filed a six-count complaint against FDA, including two counts…
2Cases cited17 opinions
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- Dalehite v. United StatesSupreme Court of the United States · 1953
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