Ferring Pharmaceuticals, Inc. v. Burwell
District Court, District of Columbia
1Opinion of the Court
MEMORANDUM OPINION
Granting in Part and Denying in Part Defendants’ Motion for Summary Judgment and Denying Plaintiff’s Motion for Summary Judgment
RUDOLPH CONTRERAS, United States District Judge
I. INTRODUCTION
Plaintiff Ferring Pharmaceuticals, Inc. (“Ferring”) is the manufacturer of PRE-POPIK, a fixed-dose combination drug product that contains three drug substances: sodium picosulfate, magnesium oxide, and anhydrous citric acid. When it submitted a New Drug Application (“NDA”) for PREPOPIK to the U.S. Food and Drug Administration (“the FDA”), Ferring sought a five-year period of marketing…
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