Prescription Polyethylene Glycol 3350; Denial of a Hearing and Order Withdrawing Approval of Abbreviated New Drug Applications; Temporary Stay of Effective Date, 36604 [2018-16148]
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36604
Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices
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Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–16178 Filed 7–27–18; 8:45 am]
BILLING CODE 4164–01–P
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.
daltland on DSKBBV9HB2PROD with NOTICES
ACTION:
Notice.
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
SUMMARY:
VerDate Sep<11>2014
20:33 Jul 27, 2018
Jkt 244001
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 § 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 § 10.35(e) were
met. Bayer Healthcare, LLC, (Bayer)
which holds an approved New Drug
Application for MiraLAX, an over-thecounter laxative containing PEG 3350,
responded. Bayer argued that the
petitioners failed to meet any of the
factors in § 10.35(e).1
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
PO 00000
Frm 00092
Fmt 4703
Sfmt 9990
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 § 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
§ 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 § 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
the stay provides that the order is stayed until
November 2, 2018, without the limitations Bayer
now requests.
E:\FR\FM\30JYN1.SGM
30JYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
