Serono Labs Inc v. Ferring Pharm. Inc.
Court of Appeals for the D.C. Circuit
1Opinion of the Court
GARLAND, Circuit Judge:
In this case we consider the validity of a district court order, preliminarily enjoining approval by the Food and Drug Administration (“FDA”) of a generic drug, that was issued at the behest of the manufacturer of the competing brand-name drug. We previously stayed the preliminary injunction pending our resolution of this appeal. Because we find plaintiff has not satisfied the standards for a preliminary injunction, and in particular has not shown a likelihood of sue- cess on the merits, we now vacate the injunction.
I
The Food, Drug, and Cosmetic Act (the “Act”) provides…
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