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· 4/26/2013

AstraZeneca Pharmaceuticals LP v. Food & Drug Administration

Citations

  • 404 U.S. App. D.C. 339
  • 713 F.3d 1134
  • 2013 WL 1776473
  • 2013 U.S. App. LEXIS 8476

How courts have described this case

Verbatim parenthetical descriptions written by other courts when citing this decision. Ranked by citation-network relevance.

  • applying Chevron to an FDA statutory interpretation contained in a letter decision
  • applying Chevron to an FDA statutory interpretation contained in a letter decision
  • “ANDAs need not include new clinical studies 2 demonstrating . . . safety or efficacy, but must propose the same basic labeling as approved for the pioneer drug.”
  • applying Chevron to FDA’s letter decision interpreting the FDCA

Source: CourtListener parenthetical corpus (CC0).

Judges: Rogers, Tatel, Sentelle

Read full opinion on CourtListener

Sourced from CourtListener / Free Law Project (CC0).

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.