[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Notices]
[Pages 3157-3158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01118]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0021]


Watson Laboratories, Inc.; Withdrawal of Approval of Abbreviated 
New Drug Applications for Prescription Pain Medications Containing More 
Than 325 Milligrams of Acetaminophen

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA and Agency) is 
withdrawing approval of an abbreviated new drug application (ANDA), 
held by Watson Laboratories, Inc. (Watson), for prescription pain 
medications that contain more than 325 milligrams (mg) of 
acetaminophen. Watson has voluntarily requested that approval of this 
application be withdrawn and has waived its opportunity for a hearing.

DATES: Approval is withdrawn as of January 23, 2018.

FOR FURTHER INFORMATION CONTACT: Jane Baluss, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6278, Silver Spring, MD 20993-0002, 301-
796-3469.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 14, 2011 
(76 FR 2691), FDA announced its plans to reduce the maximum dosage unit 
strength of acetaminophen in prescription drug products. The document 
announced FDA's conclusion that, based on a reevaluation of the 
relative risks and benefits of prescription acetaminophen products, 
fixed-combination prescription drugs containing more than 325 mg of 
acetaminophen per dosage unit (tablet or capsule) do not provide a 
sufficient margin of safety to protect the public against the serious 
risk of acetaminophen-induced liver injury. Accordingly, we asked 
product sponsors to limit the maximum amount of acetaminophen per 
dosage unit to 325 mg and, for those products containing more than 325 
mg of acetaminophen per dosage unit, to submit requests that FDA 
withdraw approval of their applications under Sec.  314.150(d) (21 CFR 
314.150(d)). FDA asked that all such requests be made before January 
14, 2014, after which date the Agency planned to initiate proceedings 
under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 355(e)). In a Federal Register document dated March 27, 
2014 (79 FR 17613),

[[Page 3158]]

FDA withdrew the approval of multiple applications containing more than 
325 mg of acetaminophen whose sponsors voluntarily requested withdrawal 
and waived their opportunity for a hearing on or before that date.
    In a letter dated November 22, 2016, Watson voluntarily requested 
that FDA withdraw approval of its ANDA 074699 for Pentazocine and 
Acetaminophen Tablets, 25 mg/650 mg, and waived its opportunity for a 
hearing. The letter also stated that the product was not manufactured 
or distributed after January 14, 2014.
    Therefore, under Sec.  314.150(d), approval of this ANDA, and all 
amendments and supplements thereto, is withdrawn (see DATES). 
Distribution of this product in interstate commerce 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)).
    The safety issue discussed in this document and the January 14, 
2011, Federal Register document is limited to products containing more 
than 325 mg of acetaminophen per dosage unit. Thus, the withdrawal of 
approval of this product does not change the approval status of any 
product with 325 mg or less of acetaminophen per dosage unit that is 
approved under the same application, or that refers to or relies on the 
withdrawn application.

    Dated: January 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01118 Filed 1-22-18; 8:45 am]
 BILLING CODE 4164-01-P


