News & Analysis as of

Administrative Procedure Act Food and Drug Administration (FDA) Abbreviated New Drug Application (ANDA)

Robins Kaplan LLP

Norwich Pharms., Inc. v. Kennedy Jr.

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: Salix holds NDAs for 200mg and 550mg Xifaxan. The 550mg strength product was approved to treat irritable bowel syndrome with diarrhea (“IBS-D indication”) and hepatic encephalopathy...more

ArentFox Schiff

New Challenge to Abortion Access Takes on FDA Drug Approvals

ArentFox Schiff on

On November 18, 2022, a collection of organizations and providers that oppose abortion filed suit against the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS), seeking — among...more

King & Spalding

D.C. Circuit Concludes that Serial Periods of Exclusivity May Be Available Under the Orphan Drug Act

King & Spalding on

On March 13, 2020, the U.S. Court of Appeals for the D.C. Circuit affirmed the D.C. District Court’s 2018 summary judgment ruling in favor of Eagle Pharmaceuticals and against the FDA, finding that (1) the Orphan Drug Act...more

McGuireWoods LLP

Otsuka’s Pediatric Labeling Dispute Seeks to Expand Orphan Drug Exclusivity

McGuireWoods LLP on

On April 13, 2015, the U.S. District Court for the District of Maryland issued an Order granting Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka America...more

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