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NOSTRUM PHARMA., LLC v. U.S. FOOD AND DRUG ADMIN.

No. 20-1525.

35 F.4th 820 (2022)

NOSTRUM PHARMACEUTICALS, LLC, Petitioner v. UNITED STATES FOOD AND DRUG ADMINISTRATION, Respondent.

United States Court of Appeals, District of Columbia Circuit.

Decided June 3, 2022.

Attorney(s) appearing for the Case

Shashank Upadhye was on the briefs for petitioner. Douglas B. Farquhar entered an appearance.

Brian M. Boynton , Acting Assistant Attorney General at the time the brief was filed, U.S. Department of Justice, Scott McIntosh and Joshua Dos Santos , Attorneys, Daniel J. Barry , Acting General Counsel, U.S. Department of Health and Human Services, Wendy Vicente , Acting Deputy Chief Counsel for Litigation, and Leslie Cohen , Associate Chief Counsel, were on the brief for respondent.

Before: Tatel and Millett, Circuit Judges, and Edwards, Senior Circuit Judge.

Nostrum Pharmaceuticals, LLC is a drug manufacturer seeking to market various strengths and formulations of generic theophylline, a drug used to treat asthma and other respiratory conditions. To that end, Nostrum submitted a supplemental abbreviated new drug application to the Food and Drug Administration ("FDA"). This application...

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