Document ID: FDA-2008-N-0549-0062
Agency: fda
Document Type: Notice
Title: Prescription Polyethylene Glycol 3350; Denial of a Hearing and Order
Withdrawing Approval of Abbreviated New Drug Applications; Temporary Stay of Effective Date
Posted Date: 2018-07-30T04:00Z

[Federal Register Volume 83, Number 146 (Monday, July 30, 2018)]
[Notices]
[Page 36604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16148]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0549]

Prescription Polyethylene Glycol 3350; Denial of a Hearing and 
Order Withdrawing Approval of Abbreviated New Drug Applications; 
Temporary Stay of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice 
that the effective date of an April 2, 2018, order denying requests for 
a hearing and withdrawing approval of abbreviated new drug applications 
(ANDAs) for certain prescription laxatives with the active ingredient 
polyethylene glycol 3350 (PEG 3350) is stayed until November 2, 2018.

DATES: FDA is staying the effective date of the April 2, 2018, order 
withdrawing approval of ANDAs for certain prescription laxatives with 
the active ingredient PEG 3350 until November 2, 2018.

ADDRESSES: For access to the docket, go to https://www.regulations.gov 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Publicly 
available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT: Julie Finegan, Office of Scientific 
Integrity, Office of the Chief Scientist, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4218, Silver Spring, MD 20993-
0002, 301-796-8618.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 2, 2018 (83 
FR 13994), FDA denied requests for hearing and issued an order 
withdrawing approval of ANDAs for certain prescription laxatives with 
the active ingredient PEG 3350. The effective date of the order was May 
2, 2018. Between April 6, 2018, and April 13, 2018, FDA received 
petitions for stay under Sec.  10.35 (21 CFR 10.35) on behalf of four 
ANDA holders: Breckenridge Pharmaceutical, Inc. and Nexgen Pharma, Inc. 
(hereafter Breckenridge/Nexgen) who submitted a joint petition; Lannett 
Company, Inc.; and Paddock Laboratories, Inc. (collectively the ANDA 
holders). Breckenridge/Nexgen, Lannett, and Paddock petitioned FDA to 
stay its order withdrawing the approval of their ANDAs for prescription 
PEG 3350 and argued that all four criteria for a mandatory stay under 
Sec.  10.35(e) were met. Bayer Healthcare, LLC, (Bayer) which holds an 
approved New Drug Application for MiraLAX, an over-the-counter laxative 
containing PEG 3350, responded. Bayer argued that the petitioners 
failed to meet any of the factors in Sec.  10.35(e).\1\
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    \1\ On April 30, 2018, Bayer filed a submission titled ``Request 
for Clarification of FDA Granting of a Petition for Stay of 
Action.'' Bayer requested that FDA clarify that the stay allowed new 
manufacturing only until May 2, 2018, with shipment of product 
permitted until November 2, 2018. Breckenridge/Nexgen responded to 
Bayer's request for clarification and argued that Bayer's submission 
should have been a petition for reconsideration and that it failed 
to meet the standards required for reconsideration. Regardless of 
whether Bayer's submission should have been a petition for 
reconsideration, FDA's letter granting the stay provides that the 
order is stayed until November 2, 2018, without the limitations 
Bayer now requests.
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    By a letter dated April 16, 2018, the Acting Chief Scientist, 
pursuant to authority delegated by the Commissioner, concluded that the 
ANDA holders had not met the criteria for a mandatory stay under Sec.  
10.35(e). The Acting Chief Scientist granted a temporary, discretionary 
stay of the effective date of the order until November 2, 2018. As 
described in the April 16, 2018, letter, based upon information 
submitted by the ANDA holders and not disputed by Bayer, it would 
likely be difficult for manufacturers of OTC PEG 3350 products to 
compensate for the removal of prescription PEG 3350 products within 30 
days. The letter explained that public health interests would not be 
served should the 30-day effective date negatively impact the 
availability of PEG 3350, particularly given that the basis of the 
withdrawal of the ANDA products is not an issue of safety or efficacy. 
The April 16, 2018, letter additionally noted that FDA has provided 
lengthier time frames to phase out manufacturing and distribution of 
affected products in other cases. While the Acting Chief Scientist 
rejected the petitioners' arguments that financial hardship and harm to 
reputation resulting from the withdrawal order rise to the level of 
irreparable injury necessary for a mandatory stay under Sec.  10.35(e), 
she agreed that there may some validity to the petitioner's concerns of 
harm to their business interests as a result of the 30-day effective 
date. The Acting Chief Scientist concluded that it is in the public 
interest and in the interest of justice to stay the effective date of 
the April 2, 2018, order until November 2, 2018.
    The parties' submissions and the Agency's orders are available at 
https://www.regulations.gov and with the Dockets Management Staff (see 
ADDRESSES).
    FDA is providing notice of the decision to grant a temporary stay 
in accordance with Sec.  10.35(f).

    Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16148 Filed 7-27-18; 8:45 am]
 BILLING CODE 4164-01-P