Legal Opinion
Cumberland Pharmaceuticals Inc. v. Food and Drug Administration
District Court, District of Columbia
Decided September 30, 2013No. Civil Action No. 2012-1842PublishedCited by 6 opinions
1Opinion of the Court
UNDER SEAL
MEMORANDUM OPINION
REGGIE B. WALTON, United States District Judge
Plaintiff Cumberland Pharmaceuticals Inc. (“Cumberland”) brings suit against the Food & Drug Administration (“FDA”), FDA Commissioner Margaret A. Hamburg, and Department of Health and Human Services Secretary Kathleen Sebelius (collectively “FDA”), alleging that the FDA’s denial of Cumberland’s May 18, 2012 citizen petition and simultaneous approval of InnoPharma, Inc.’s (“InnoPharma”) abbreviated new drug application for acetylcysteine injection was arbitrary, capricious, an abuse of discretion, or otherwise not in…
2Cases cited24 opinions
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- Camp v. PittsSupreme Court of the United States · 1973
- Amer Bioscience Inc v. Thompson, Tommy G.Court of Appeals for the D.C. Circuit · 2001
- Marshall County Health Care Authority v. Donna E. Shalala, Secretary of the Department of Health and Human ServicesCourt of Appeals for the D.C. Circuit · 1993
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3Cited by6 opinions
- State of Louisiana v. SalazarDistrict Court, District of Columbia · 2016
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