News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Statutory Interpretation Pharmaceutical Industry

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

Wilson Sonsini Goodrich & Rosati

Microbes and Medical Foods: A Growing Area of Commercial Importance

The 2nd Annual Microbiome Movement conference, recently held in San Diego, California, highlighted the growing importance of microbes as the basis for various commercial products. Microbe-containing products regulated by the...more

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