Document ID: FDA-2019-N-0361-0001
Agency: fda
Document Type: Notice
Title: Takeda Pharmaceuticals U.S.A., Inc.; Withdrawal of Approval of a New Drug Application for OMONTYS (peginesatide) Injection
Posted Date: 2019-02-13T05:00Z

[Federal Register Volume 84, Number 30 (Wednesday, February 13, 2019)]
[Notices]
[Pages 3795-3796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02146]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0361]

Takeda Pharmaceuticals U.S.A., Inc.; Withdrawal of Approval of a 
New Drug Application for OMONTYS (peginesatide) Injection

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of new drug application (NDA) 202799 for OMONTYS (peginesatide) 
Injection, held by Takeda Pharmaceuticals U.S.A., Inc. (Takeda USA). 
Takeda Development Center America, Inc., on behalf of Takeda USA, 
requested withdrawal of approval of this application under relevant FDA 
regulations and, in so doing, has waived its opportunity for a hearing.

DATES: Approval is withdrawn as of February 13, 2019.

[[Page 3796]]

FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Office of 
Regulatory Policy, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6262, 
Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION: NDA 202799 for OMONTYS (peginesatide) 
Injection, 1 milligram (mg)/0.5 milliliter (mL), 2 mg/0.5 mL, 3 mg/0.5 
mL, 4 mg/0.5 mL, 5 mg/0.5 mL, 6 mg/0.5 mL, 10 mg/mL, and 20 mg/2 mL, 
was received on May 8, 2011, under section 505(b) of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(b)). FDA approved NDA 
202799 on March 27, 2012, for treatment of anemia due to chronic kidney 
disease in adult patients on dialysis.
    On February 23, 2013, Affymax, Inc. and Takeda voluntarily recalled 
all lots of OMONTYS and suspended its marketing as a result of 
postmarketing reports of serious hypersensitivity reactions, including 
anaphylaxis, which can be life-threatening or fatal.
    Takeda subsequently requested that FDA withdraw approval of NDA 
202799 under 21 CFR 314.150(d) (Sec.  314.150(d)) and waived its 
opportunity for a hearing. Accordingly, under Sec.  314.150(d), 
approval of NDA 202799, and all amendments and supplements thereto, is 
withdrawn. Distribution of OMONTYS (peginesatide) Injection, 1 mg/0.5 
mL, 2 mg/0.5 mL, 3 mg/0.5 mL, 4 mg/0.5 mL, 5 mg/0.5 mL, 6 mg/0.5 mL, 10 
mg/mL, and 20 mg/2 mL, without an approved application is illegal and 
subject to regulatory action (see sections 505(a) and 301(d) of the 
FD&C Act (21 U.S.C. 355(a) and 331(d)).

    Dated: February 8, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02146 Filed 2-12-19; 8:45 am]
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