Mallinckrodt Inc. et al.; Withdrawal of Approval of Five New Drug Applications, 14016-14017 [2018-06579]
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14016
Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
submitted by Nexgen (Nexgen Objection
at 78–82). According to Nexgen, its
pending citizen petition requests that
FDA find that the prescription MiraLAX
NDA was not withdrawn for reasons of
safety and efficacy and to declare
Nexgen’s prescription ANDA as the new
RLD drug for prescription PEG 3350
products (Objection at 79). It is not
necessary to finalize the TFM for OTC
laxatives or to respond to Nexgen’s
pending citizen petition prior to the
withdrawal of the ANDAs. As discussed
elsewhere in this order, the OTC
MiraLAX labeling is consistent with the
TFM for OTC laxatives with respect to
the use of the phrase ‘‘relieves’’ versus
‘‘treats’’ and the instruction to ‘‘use no
more than 7 days’’ and ‘‘Stop use and
ask a doctor if . . . you need to use a
laxative for longer than 1 week.’’
However, this labeling does not change
the factors relevant to determining
whether there is a meaningful difference
between the prescription and
nonprescription PEG 3350 products. If
an order is entered withdrawing the
approval of the ANDAs, the issues
raised in the citizen petition will be
moot.
Nexgen complains that FDA largely
based its draft proposed order on a
January 2013 letter from Merck rather
than more carefully reviewing and
responding to each argument raised by
the ANDA holders, rendering the order
suspect (Nexgen Objection at 75–76). In
fact, both the Merck letter and the draft
proposed order were written in response
to the issues and evidence submitted by
the ANDA holders. The draft proposed
order provided a lengthy analysis
addressing the arguments and evidence
submitted by the ANDA holders. The
fact that the draft proposed order
ultimately reached the same conclusion
urged by the NDA holder (and the result
proposed by CDER in the NOOH) does
not render that order ‘‘suspect.’’
In sum, the Commissioner believes
that the change in prescription to
nonprescription status was a complete
switch. In addition, the Commissioner
concludes that there is not a meaningful
difference between the prescription and
nonprescription products approved by
FDA based on the arguments discussed
in this section. The Commissioner finds
that the ANDA holders have failed to
raise a genuine and substantial issue of
fact regarding a meaningful difference
between prescription and
nonprescription MiraLAX that requires
a hearing. The Commissioner does not
find the arguments advanced by the PEG
3350 ANDA holders on the topics
discussed in this section persuasive and
is entering summary judgment against
them.
IV. Findings and Order
Based upon the above, the
Commissioner finds that the PEG 3350
ANDA holders have failed to raise a
genuine and substantial issue of fact
requiring a hearing in their responses to
the NOOH. A hearing, therefore, is not
required under § 12.24(b). The PEG 3350
ANDA holders did not submit any
specifically identified reliable evidence
demonstrating that a hearing is
necessary. Other evidence submitted
was not material to the issues in this
proceeding. Even if the Commissioner
were to accept these factual assertions
as having some weight, such evidence
does not present a sufficient area of
disagreement to require an evidentiary
hearing. Rather, the evidence is ‘‘so onesided that [FDA] must prevail as a
matter of law.’’ (See Anderson v. Liberty
Lobby, Inc., 477 U.S. 242, 252 (1986).)
In addition to finding that the ANDA
holders have failed to raise a genuine
and substantial issue of fact that
requires a hearing, the Commissioner
does not find the arguments advanced
by the PEG 3350 ANDA holders
persuasive and is entering summary
judgment against them under
§ 314.200(g). There is no meaningful
difference between the ANDA holders’
PEG 3350 products and OTC MiraLAX.
The labeling of the ANDA holders’ PEG
3350 products is false and misleading
because it bears the ‘‘Rx only’’ symbol
when FDA has determined in approving
OTC MiraLAX that the drug can be used
safely and effectively in the
nonprescription setting and does not
meet the criteria for a prescription drug
in 503(b)(1) of the FD&C Act. This false
and misleading labeling was not
corrected within a reasonable time after
receipt of written notice from FDA.
Therefore, under section 505(e) of the
FD&C Act and under authority
delegated to the Commissioner, the PEG
3350 ANDA holders’ requests for a
hearing are denied.
It is ordered, that pursuant to section
505(e) of the FD&C Act (21 U.S.C.
355(e)), that approval of the following
ANDAs: ANDA 76–652 held by Kremers
Urban Pharmaceuticals, Inc.; ANDA 77–
736 held by Breckenridge
Pharmaceutical, Inc.; ANDA 77–706
held by Nexgen Pharma, Inc. (formerly
known as Anabolic Laboratories, Inc.);
ANDA 77–893 held by Paddock
Laboratories, LLC.; and ANDA 77–445
held by Teva Pharmaceutical, USA; and
all amendments and supplements to
them, be and hereby are withdrawn,
effective May 2, 2018.
Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06537 Filed 3–30–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1141]
Mallinckrodt Inc. et al.; Withdrawal of
Approval of Five New Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of five new drug applications
(NDAs) from multiple applicants. The
holders of the applications notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of
May 2, 2018.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: The
holders of the applications listed in the
table have informed FDA that these drug
products are no longer marketed and
have requested that FDA withdraw
approval of the applications under the
process in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUMMARY:
Application No.
Drug
Applicant
NDA 006383 ........................
Methadone Hydrochloride (HCl) Powder, 50 grams (g)/
bottle, 100 g/bottle, and 500 g/bottle.
Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO
63042.
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Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
14017
Application No.
Drug
Applicant
NDA 020716 ........................
Vicoprofen (hydrocodone bitartrate and ibuprofen) Tablets, 7.5 milligrams (mg)/200 mg.
Ultram ER (tramadol HCl) Extended-Release Tablets,
100 mg, 200 mg, and 300 mg.
Troxyca ER (oxycodone HCl and naltrexone HCl) Extended-Release Capsules, 10 mg/1.2 mg, 20 mg/2.4
mg, 30 mg/3.6 mg, 40 mg/4.8 mg, 60 mg/7.2 mg,
and 80 mg/9.6 mg.
Vantrela ER (hydrocodone bitartrate) Extended-Release
Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg.
AbbVie Inc., 1 North Waukegan Rd., North Chicago, IL
60064.
Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
Pfizer Inc., 235 East 42nd St., New York, NY 10017.
NDA 021692 ........................
NDA 207621 ........................
NDA 207975 ........................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of May 2, 2018.
Introduction or delivery for introduction
into interstate commerce of products
without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on May 2, 2018
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06579 Filed 3–30–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Committee on Rural
Health and Human Services
Health Resources and Service
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, notice
is hereby given that a meeting is
scheduled for the National Advisory
Committee on Rural Health and Human
Services (NACRHHS). This meeting will
be open to the public. Information about
the NACRHHS and the agenda for this
meeting can be obtained by accessing
the NACRHHS website at https://
www.hrsa.gov/advisorycommittees/
rural/.
DATES: The meeting will be held on
April 16, 2018, from 8:45 a.m.–5:00 p.m.
EDT, April 17, 2018, from 8:30 a.m.–
5:15 p.m. EDT, and April 18, 2018, from
8:30 a.m.–11:00 a.m. EDT.
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SUMMARY:
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Teva Branded Pharmaceutical Products R&D, Inc., 41
Moores Rd., P.O. Box 4011, Frazer, PA 19355.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
Services is hereby giving notice that a
meeting is scheduled to be held of the
National Vaccine Advisory Committee
(NVAC). The meeting will be open to
the public via teleconference; a public
comment session will be held during
the meeting.
DATES: The meeting will be held on May
3, 2018, from 10:30 a.m. to 12:30 p.m.
ET. The confirmed meeting times and
agenda will be posted on the NVAC
website at https://www.hhs.gov/nvpo/
nvac/meetings/ as soon as
they become available.
ADDRESSES: Instructions regarding
attending this meeting will be posted
one week prior to the meeting at: https://
www.hhs.gov/nvpo/nvac/meetings/
index.html. Pre-registration is required
for members of the public who wish to
attend the meeting and who wish to
participate in the public comment
session. Individuals who wish to attend
the meeting and/or participate in the
public comment session should register
at https://www.hhs.gov/nvpo/nvac/
meetings/.
FOR FURTHER INFORMATION CONTACT:
National Vaccine Program Office, U.S.
Department of Health and Human
Services, Room 715H, Hubert H.
Humphrey Building, 200 Independence
Avenue SW, Washington, DC 20201.
Phone: (202) 690–5566; email: nvac@
hhs.gov.
[FR Doc. 2018–06651 Filed 3–30–18; 8:45 am]
SUPPLEMENTARY INFORMATION:
This meeting will be held at
The Saratoga Hilton. The address for the
meeting is 534 Broadway Saratoga
Springs, NY 12866–2209, (855) 605–
0316.
FOR FURTHER INFORMATION CONTACT:
Steve Hirsch, MSLS, Administrative
Coordinator, NACRHHS, HRSA,
17W29–C, 5600 Fishers Lane, Rockville,
MD 20857, Telephone (301) 443–0835,
Fax (301) 443–2803.
SUPPLEMENTARY INFORMATION:
NACRHHS provides counsel and
recommendations to the Secretary with
respect to the delivery, research,
development, and administration of
health and human services in rural
areas. During the meeting the
Committee will examine the issues of
Assessing and Mitigating the Effect of
Adverse Childhood Experiences and
Health Insurance Markets in Rural
Areas; conduct site visits to the
Adirondack Health Institute in Glens
Falls, New York and St. Vincent de Paul
Catholic Church in Cobleskill, New
York, to visit the Head Start Program;
and summarize key findings and
develop a work plan for the next
quarter. Members of the public will also
have the opportunity to provide
comments.
ADDRESSES:
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Vaccine
Advisory Committee
National Vaccine Program
Office, Office of the Assistant Secretary
for Health, Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
SUMMARY:
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Pursuant
to Section 2101 of the Public Health
Service Act (42 U.S.C. 300aa–1), the
Secretary of Health and Human Services
was mandated to establish the National
Vaccine Program to achieve optimal
prevention of human infectious diseases
through immunization and to achieve
optimal prevention against adverse
reactions to vaccines. The NVAC was
established to provide advice and make
recommendations to the Director of the
National Vaccine Program on matters
related to the Program’s responsibilities.
The Assistant Secretary for Health
serves as Director of the National
Vaccine Program. The public meeting
will be dedicated to the deliberation of
the draft recommendations written by
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]]>Agencies
[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Pages 14016-14017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06579]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1141]
Mallinckrodt Inc. et al.; Withdrawal of Approval of Five New Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of five new drug applications (NDAs) from multiple applicants. The
holders of the applications notified the Agency in writing that the
drug products were no longer marketed and requested that the approval
of the applications be withdrawn.
DATES: Approval is withdrawn as of May 2, 2018.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of the applications listed in
the table have informed FDA that these drug products are no longer
marketed and have requested that FDA withdraw approval of the
applications under the process in Sec. 314.150(c) (21 CFR 314.150(c)).
The applicants have also, by their requests, waived their opportunity
for a hearing. Withdrawal of approval of an application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 006383.................. Methadone Mallinckrodt Inc.,
Hydrochloride (HCl) 675 McDonnell
Powder, 50 grams Blvd., Hazelwood,
(g)/bottle, 100 g/ MO 63042.
bottle, and 500 g/
bottle.
[[Page 14017]]
NDA 020716.................. Vicoprofen AbbVie Inc., 1 North
(hydrocodone Waukegan Rd., North
bitartrate and Chicago, IL 60064.
ibuprofen) Tablets,
7.5 milligrams (mg)/
200 mg.
NDA 021692.................. Ultram ER (tramadol Valeant
HCl) Extended- Pharmaceuticals
Release Tablets, North America LLC,
100 mg, 200 mg, and 400 Somerset
300 mg. Corporate Blvd.,
Bridgewater, NJ
08807.
NDA 207621.................. Troxyca ER Pfizer Inc., 235
(oxycodone HCl and East 42nd St., New
naltrexone HCl) York, NY 10017.
Extended-Release
Capsules, 10 mg/1.2
mg, 20 mg/2.4 mg,
30 mg/3.6 mg, 40 mg/
4.8 mg, 60 mg/7.2
mg, and 80 mg/9.6
mg.
NDA 207975.................. Vantrela ER Teva Branded
(hydrocodone Pharmaceutical
bitartrate) Products R&D, Inc.,
Extended-Release 41 Moores Rd., P.O.
Tablets, 15 mg, 30 Box 4011, Frazer,
mg, 45 mg, 60 mg, PA 19355.
and 90 mg.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of May
2, 2018. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on May 2, 2018 may continue to be dispensed until the
inventories have been depleted or the drug products have reached their
expiration dates or otherwise become violative, whichever occurs first.
Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06579 Filed 3-30-18; 8:45 am]
BILLING CODE 4164-01-P
