83 FR 14016 - Mallinckrodt Inc. et al.; Withdrawal of Approval of Five New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 63 (April 2, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 63 (April 2, 2018)
| Page Range | 14016-14017 | |
| FR Document | 2018-06579 |
[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)] [Notices] [Pages 14016-14017] From the Federal Register Online [www.thefederalregister.org] [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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of May 2, 2018.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
![14016 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
submitted by Nexgen (Nexgen Objection a hearing. The Commissioner does not Pharmaceutical, Inc.; ANDA 77–706
at 78–82). According to Nexgen, its find the arguments advanced by the PEG held by Nexgen Pharma, Inc. (formerly
pending citizen petition requests that 3350 ANDA holders on the topics known as Anabolic Laboratories, Inc.);
FDA find that the prescription MiraLAX discussed in this section persuasive and ANDA 77–893 held by Paddock
NDA was not withdrawn for reasons of is entering summary judgment against Laboratories, LLC.; and ANDA 77–445
safety and efficacy and to declare them. held by Teva Pharmaceutical, USA; and
Nexgen’s prescription ANDA as the new all amendments and supplements to
IV. Findings and Order
RLD drug for prescription PEG 3350 them, be and hereby are withdrawn,
products (Objection at 79). It is not Based upon the above, the effective May 2, 2018.
necessary to finalize the TFM for OTC Commissioner finds that the PEG 3350 Dated: March 22, 2018.
laxatives or to respond to Nexgen’s ANDA holders have failed to raise a
Leslie Kux,
pending citizen petition prior to the genuine and substantial issue of fact
Associate Commissioner for Policy.
withdrawal of the ANDAs. As discussed requiring a hearing in their responses to
the NOOH. A hearing, therefore, is not [FR Doc. 2018–06537 Filed 3–30–18; 8:45 am]
elsewhere in this order, the OTC
MiraLAX labeling is consistent with the required under § 12.24(b). The PEG 3350 BILLING CODE 4164–01–P
TFM for OTC laxatives with respect to ANDA holders did not submit any
the use of the phrase ‘‘relieves’’ versus specifically identified reliable evidence
demonstrating that a hearing is DEPARTMENT OF HEALTH AND
‘‘treats’’ and the instruction to ‘‘use no
necessary. Other evidence submitted HUMAN SERVICES
more than 7 days’’ and ‘‘Stop use and
ask a doctor if . . . you need to use a was not material to the issues in this Food and Drug Administration
laxative for longer than 1 week.’’ proceeding. Even if the Commissioner
However, this labeling does not change were to accept these factual assertions [Docket No. FDA–2018–N–1141]
the factors relevant to determining as having some weight, such evidence
whether there is a meaningful difference does not present a sufficient area of Mallinckrodt Inc. et al.; Withdrawal of
between the prescription and disagreement to require an evidentiary Approval of Five New Drug
nonprescription PEG 3350 products. If hearing. Rather, the evidence is ‘‘so one- Applications
an order is entered withdrawing the sided that [FDA] must prevail as a
AGENCY: Food and Drug Administration,
approval of the ANDAs, the issues matter of law.’’ (See Anderson v. Liberty
HHS.
raised in the citizen petition will be Lobby, Inc., 477 U.S. 242, 252 (1986).)
moot. In addition to finding that the ANDA ACTION: Notice.
Nexgen complains that FDA largely holders have failed to raise a genuine SUMMARY: The Food and Drug
based its draft proposed order on a and substantial issue of fact that Administration (FDA) is withdrawing
January 2013 letter from Merck rather requires a hearing, the Commissioner approval of five new drug applications
than more carefully reviewing and does not find the arguments advanced (NDAs) from multiple applicants. The
responding to each argument raised by by the PEG 3350 ANDA holders holders of the applications notified the
the ANDA holders, rendering the order persuasive and is entering summary Agency in writing that the drug
suspect (Nexgen Objection at 75–76). In judgment against them under products were no longer marketed and
fact, both the Merck letter and the draft § 314.200(g). There is no meaningful requested that the approval of the
proposed order were written in response difference between the ANDA holders’ applications be withdrawn.
to the issues and evidence submitted by PEG 3350 products and OTC MiraLAX.
DATES: Approval is withdrawn as of
the ANDA holders. The draft proposed The labeling of the ANDA holders’ PEG
order provided a lengthy analysis 3350 products is false and misleading May 2, 2018.
addressing the arguments and evidence because it bears the ‘‘Rx only’’ symbol FOR FURTHER INFORMATION CONTACT:
submitted by the ANDA holders. The when FDA has determined in approving Florine P. Purdie, Center for Drug
fact that the draft proposed order OTC MiraLAX that the drug can be used Evaluation and Research, Food and
ultimately reached the same conclusion safely and effectively in the Drug Administration, 10903 New
urged by the NDA holder (and the result nonprescription setting and does not Hampshire Ave., Bldg. 51, Rm. 6248,
proposed by CDER in the NOOH) does meet the criteria for a prescription drug Silver Spring, MD 20993–0002, 301–
not render that order ‘‘suspect.’’ in 503(b)(1) of the FD&C Act. This false 796–3601.
In sum, the Commissioner believes and misleading labeling was not SUPPLEMENTARY INFORMATION: The
that the change in prescription to corrected within a reasonable time after holders of the applications listed in the
nonprescription status was a complete receipt of written notice from FDA. table have informed FDA that these drug
switch. In addition, the Commissioner Therefore, under section 505(e) of the products are no longer marketed and
concludes that there is not a meaningful FD&C Act and under authority have requested that FDA withdraw
difference between the prescription and delegated to the Commissioner, the PEG approval of the applications under the
nonprescription products approved by 3350 ANDA holders’ requests for a process in § 314.150(c) (21 CFR
FDA based on the arguments discussed hearing are denied. 314.150(c)). The applicants have also,
in this section. The Commissioner finds It is ordered, that pursuant to section by their requests, waived their
that the ANDA holders have failed to 505(e) of the FD&C Act (21 U.S.C. opportunity for a hearing. Withdrawal
raise a genuine and substantial issue of 355(e)), that approval of the following of approval of an application or
fact regarding a meaningful difference ANDAs: ANDA 76–652 held by Kremers abbreviated application under
daltland on DSKBBV9HB2PROD with NOTICES
between prescription and Urban Pharmaceuticals, Inc.; ANDA 77– § 314.150(c) is without prejudice to
nonprescription MiraLAX that requires 736 held by Breckenridge refiling.
Application No. Drug Applicant
NDA 006383 ........................ Methadone Hydrochloride (HCl) Powder, 50 grams (g)/ Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO
bottle, 100 g/bottle, and 500 g/bottle. 63042.
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14079/page/1.svg)
![Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices 14017
Application No. Drug Applicant
NDA 020716 ........................ Vicoprofen (hydrocodone bitartrate and ibuprofen) Tab- AbbVie Inc., 1 North Waukegan Rd., North Chicago, IL
lets, 7.5 milligrams (mg)/200 mg. 60064.
NDA 021692 ........................ Ultram ER (tramadol HCl) Extended-Release Tablets, Valeant Pharmaceuticals North America LLC, 400 Som-
100 mg, 200 mg, and 300 mg. erset Corporate Blvd., Bridgewater, NJ 08807.
NDA 207621 ........................ Troxyca ER (oxycodone HCl and naltrexone HCl) Ex- Pfizer Inc., 235 East 42nd St., New York, NY 10017.
tended-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 (hydrocodone bitartrate) Extended-Release Teva Branded Pharmaceutical Products R&D, Inc., 41
Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg. Moores Rd., P.O. Box 4011, Frazer, PA 19355.
Therefore, approval of the ADDRESSES: This meeting will be held at Services is hereby giving notice that a
applications listed in the table, and all The Saratoga Hilton. The address for the meeting is scheduled to be held of the
amendments and supplements thereto, meeting is 534 Broadway Saratoga National Vaccine Advisory Committee
is hereby withdrawn as of May 2, 2018. Springs, NY 12866–2209, (855) 605– (NVAC). The meeting will be open to
Introduction or delivery for introduction 0316. the public via teleconference; a public
into interstate commerce of products FOR FURTHER INFORMATION CONTACT: comment session will be held during
without approved new drug Steve Hirsch, MSLS, Administrative the meeting.
applications violates section 301(a) and Coordinator, NACRHHS, HRSA, DATES: The meeting will be held on May
(d) of the Federal Food, Drug, and 17W29–C, 5600 Fishers Lane, Rockville, 3, 2018, from 10:30 a.m. to 12:30 p.m.
Cosmetic Act (21 U.S.C. 331(a) and (d)). MD 20857, Telephone (301) 443–0835, ET. The confirmed meeting times and
Drug products that are listed in the table Fax (301) 443–2803. agenda will be posted on the NVAC
that are in inventory on May 2, 2018 SUPPLEMENTARY INFORMATION: website at http://www.hhs.gov/nvpo/
may continue to be dispensed until the NACRHHS provides counsel and nvac/meetings/index.html as soon as
inventories have been depleted or the recommendations to the Secretary with they become available.
drug products have reached their respect to the delivery, research, ADDRESSES: Instructions regarding
expiration dates or otherwise become development, and administration of attending this meeting will be posted
violative, whichever occurs first. health and human services in rural one week prior to the meeting at: http://
Dated: March 21, 2018. areas. During the meeting the www.hhs.gov/nvpo/nvac/meetings/
Leslie Kux, Committee will examine the issues of index.html. Pre-registration is required
Associate Commissioner for Policy. Assessing and Mitigating the Effect of for members of the public who wish to
[FR Doc. 2018–06579 Filed 3–30–18; 8:45 am] Adverse Childhood Experiences and attend the meeting and who wish to
BILLING CODE 4164–01–P
Health Insurance Markets in Rural participate in the public comment
Areas; conduct site visits to the session. Individuals who wish to attend
Adirondack Health Institute in Glens the meeting and/or participate in the
DEPARTMENT OF HEALTH AND Falls, New York and St. Vincent de Paul public comment session should register
HUMAN SERVICES Catholic Church in Cobleskill, New at http://www.hhs.gov/nvpo/nvac/
York, to visit the Head Start Program; meetings/index.html.
Health Resources and Services and summarize key findings and FOR FURTHER INFORMATION CONTACT:
Administration develop a work plan for the next National Vaccine Program Office, U.S.
quarter. Members of the public will also Department of Health and Human
National Advisory Committee on Rural have the opportunity to provide Services, Room 715H, Hubert H.
Health and Human Services comments. Humphrey Building, 200 Independence
AGENCY: Health Resources and Service Amy P. McNulty, Avenue SW, Washington, DC 20201.
Administration (HRSA), Department of Acting Director, Division of the Executive
Phone: (202) 690–5566; email: nvac@
Health and Human Services (HHS). Secretariat. hhs.gov.
ACTION: Notice of meeting. [FR Doc. 2018–06651 Filed 3–30–18; 8:45 am] SUPPLEMENTARY INFORMATION: Pursuant
BILLING CODE 4165–15–P to Section 2101 of the Public Health
SUMMARY: In accordance with the Service Act (42 U.S.C. 300aa–1), the
Federal Advisory Committee Act, notice Secretary of Health and Human Services
is hereby given that a meeting is DEPARTMENT OF HEALTH AND was mandated to establish the National
scheduled for the National Advisory HUMAN SERVICES Vaccine Program to achieve optimal
Committee on Rural Health and Human prevention of human infectious diseases
Services (NACRHHS). This meeting will Meeting of the National Vaccine through immunization and to achieve
be open to the public. Information about Advisory Committee optimal prevention against adverse
the NACRHHS and the agenda for this reactions to vaccines. The NVAC was
AGENCY: National Vaccine Program
meeting can be obtained by accessing established to provide advice and make
Office, Office of the Assistant Secretary
the NACRHHS website at http:// recommendations to the Director of the
for Health, Office of the Secretary,
daltland on DSKBBV9HB2PROD with NOTICES
www.hrsa.gov/advisorycommittees/ National Vaccine Program on matters
Department of Health and Human
rural/. related to the Program’s responsibilities.
Services.
DATES: The meeting will be held on ACTION: Notice. The Assistant Secretary for Health
April 16, 2018, from 8:45 a.m.–5:00 p.m. serves as Director of the National
EDT, April 17, 2018, from 8:30 a.m.– SUMMARY: As stipulated by the Federal Vaccine Program. The public meeting
5:15 p.m. EDT, and April 18, 2018, from Advisory Committee Act, the will be dedicated to the deliberation of
8:30 a.m.–11:00 a.m. EDT. Department of Health and Human the draft recommendations written by
VerDate Sep<11>2014 19:06 Mar 30, 2018 Jkt 244001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1](https://thefederalregister.org/doc/83_FR_14079/page/2.svg)
Document Created: 2018-11-01 09:08:53
Document Modified: 2018-11-01 09:08:53
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Approval is withdrawn as of May 2, 2018. | |
| 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. | |
| FR Citation | 83 FR 14016 |
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