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ATHENEX INC. v. AZAR

Case No. 19-cv-00603 (APM).

397 F.Supp.3d 56 (2019)

ATHENEX INC., et al., Plaintiffs, v. Alex M. AZAR II, et al., Defendants.

United States District Court, District of Columbia.

Signed August 1, 2019.

Editors Note
Applicable Law: 05 U.S.C. § 702
Cause: 05 U.S.C. § 702 Administrative Procedure Act
Nature of Suit: 890 Other Statutory Actions
Source: PACER

Attorney(s) appearing for the Case

Christopher H. Marraro , Gilbert S. Keteltas , Thomas Edward Hogan , Baker & Hostetler LLP, Washington, DC, Bridget Springer McCabe , Baker & Hostetler LLP, Los Angeles, CA, for Plaintiffs.

James William Harlow , U.S. Department of Justice, Washington, DC, for Defendants.

MEMORANDUM OPINION

I. INTRODUCTION

In 2013, Congress added Section 503B to the Food, Drug, and Cosmetic Act, creating a new category of drug manufacturer known as an "outsourcing facility." Such facilities are permitted to sell large quantities of compounded...

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