U.S. Court of Appeals for the D.C. Circuit, 2007

Apotex, Inc. v. Food & Drug Administration

U.S. Court of Appeals for the D.C. Circuit · Decided February 23, 2007

226 F. App'x 4

Counsel

Arthur Ya-Shih Tsien, Olsson, Frank & Weeda, Washington, DC, Christine J. Siwik, William Andrew Rakoczy, Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL, for Appellant., Eric Michael Blumberg, Food & Drug Administration, Rockville, MD, Eugene M. Thirolf, Jr., Andrew E. Clark, Attorney, Douglas William Stearn, U.S. Department of Justice, Office of Consumer Litigation, Daniel Meron, General Counsel, U.S. Department of Health & Human Services, Office of General Counsel, Peter Douglas Keisler, U.S. Department of Justice, Office of the Deputy Atty. Gen., Washington, DC, for Appellees.

Cases that cite this one

8 later published cases cite this decision.

Aqua Products, Inc. v. Matal (Fed. Cir. 2017)
Mylan Pharmaceuticals, Inc. v. United States Food & Drug Administration (District Court, N.D. West Virginia 2014)
Board of Trustees of the Bakery Drivers Local 550 and Industry Pension Fund v. Pension Benefit Guaranty Corporation (District Court, E.D. New York 2023)
National Association for Home Care & Hospice, Inc. v. Sebelius (District Court, District of Columbia 2015)
Takeda Pharmaceuticals, U.S.A., Inc. v. Burwell (District Court, District of Columbia 2015)
National Automobile Dealers Association v. Federal Trade Commission (District Court, District of Columbia 2012)
Viropharma Incorporated v. Hamburg (District Court, District of Columbia 2012)
Hi-Tech Pharmacal Co. v. United States Food & Drug Administration (District Court, District of Columbia 2008)

This list shows which later cases cite this one. It does not say how they treated it, and no review of that has been done. Not a substitute for Shepard’s or KeyCite — verify before relying.

Opinion of the Court

JUDGMENT

PER CURIAM.

This appeal was considered on the record from the United States District Court for the District of Columbia and on the briefs and arguments by the parties. The Court has determined that the issues presented occasion no need for an opinion. See D.C.Cir. R. 36(b). It is

ORDERED AND ADJUDGED that the judgment of the district court— accompanied by its thoughtful opinion — is affirmed. We add only two points. The first is that the district judge’s opinion, which grants Chevron deference to the FDA’s statutory interpretation of 21 U.S.C. § 355(j)(5)(B)(iv) embodied in FDA approval letters (i.e., informal adjudications), is supported by the Supreme Court’s post-Mead decision in Barnhart v. Walton, 535 U.S. 212, 222, 122 S.Ct. 1265, 152 L.Ed.2d 330 (2002), as well as our own decision in Mylan Laboratories, Inc. v. Thompson, 389 F.3d 1272, 1279-80 (D.C.Cir. 2004). Moreover, the FDA’s interpretation of 21 U.S.C. § 355(j)(5)(B)(iv) is clearly supported by its regulation, 21 C.F.R. § 314.107(c)(1), which also warrants Chevron deference under United States v. Mead Corp., 533 U.S. 218, 121 S.Ct. 2164, 150 L.Ed.2d 292 (2001).

Pursuant to D.C. Circuit Rule 36, this disposition will not be published. The Clerk is directed to withhold issuance of the mandate herein until seven days after resolution of any timely petition for rehearing or rehearing en banc. See Fed. R.App. P. 41(b); D.C.Cir. Rule 41.

Case-law data current through December 31, 2025. Source: CourtListener bulk data.