Janssen Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 16 New Drug Applications; Correction, 54581 [2020-19364]
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Federal Register / Vol. 85, No. 171 / Wednesday, September 2, 2020 / Notices
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1117]
Janssen Pharmaceuticals, Inc., et al.;
Withdrawal of Approval of 16 New
Drug Applications; Correction
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice; correction.
AGENCY:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on May 14, 2020. The
document announced the withdrawal of
approval (as of June 15, 2020) of 16 new
drug applications (NDAs) from multiple
applicants. The document indicated that
FDA was withdrawing approval of NDA
050641, Monodox (doxycycline
monohydrate) Capsules, Equivalent to
(EQ) 50 milligrams (mg) base, EQ 75 mg
base, and EQ 100 mg base, after
receiving a withdrawal request from
Aqua Pharmaceuticals, LLC, 707
Eagleview Blvd., Suite 200, Exton, PA
19341. Before FDA withdrew the
approval of NDA 050641, Aqua
Pharmaceuticals, LLC, informed FDA
that it did not want the approval of the
NDA withdrawn. Because Aqua
Pharmaceuticals, LLC, timely requested
that approval of the NDA not be
withdrawn, the approval of NDA
050641 is still in effect.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
In the
Federal Register of May 14, 2020 (85 FR
28950), appearing on page 28950 in FR
Doc. 2020–10367, the following
correction is made:
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Exemption (HDE))
2. ELANA SURGICAL KIT (HDE)
17:33 Sep 01, 2020
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SUMMARY:
1. BUTRANS (buprenorphine
transdermal system)
2. CANASA (mesalamine suppositories
for rectal use)
3. DESCOVY (emtricitabine and
tenofovir alafenamide)
4. DRAXIMAGE DTPA (technetium TC–
99m pentetate kit) injection and
inhalation
5. DYSPORT (abobotulinumtoxinA)
6. GENVOYA (elvitegravir, cobicistat,
emtricitabine, and tenofovir
alafenamide) oral tablets
7. LUMASON (sulfur hexafluoride lipidtype A microspheres) injectable
suspension
8. LUMIFY (brimonidine tartrate) OTC
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(mg) + lamivudine 300 mg +
tenofovir disoproxil fumarate 300
mg) and SYMFI (efavirenz 600 mg
+ lamivudine 300 mg + tenofovir
disoproxil fumarate 300 mg)
14. TRIUMEQ (abacavir, dolutegravir,
and lamivudine)
15. XEPI (ozenoxacin)
VerDate Sep<11>2014
[FR Doc. 2020–19385 Filed 9–1–20; 8:45 am]
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54581
On page 28951, in the table, the entry
for NDA 050641 is removed.
Dated: August 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–19364 Filed 9–1–20; 8:45 am]
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Statement of Organization, Functions,
and Delegations of Authority
August 27, 2020.
Office of the General Counsel,
Office of the Secretary, Department of
Health and Human Services.
This document revises the Statement
of Organization, Functions, and
Delegations of Authority for the
Department of Health and Human
Services, Office of the General Counsel
(OGC) as published on August 4, 2020
(85 FR 47228) to correct a typographical
error and to better reflect the functions
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Statement is retracted and replaced by
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order of succession, and changes in the
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Statement of Organization incorporates
all amendments, as may be amended
herein, after the issuance of the last
compiled Statement of Organization in
1973. See 38 FR 17032 (June 28, 1973).
SUPPLEMENTARY INFORMATION: The Office
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Section I. Mission
The Mission of the Office of the
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[Federal Register Volume 85, Number 171 (Wednesday, September 2, 2020)]
[Notices]
[Page 54581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19364]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1117]
Janssen Pharmaceuticals, Inc., et al.; Withdrawal of Approval of
16 New Drug Applications; Correction
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register on May 14, 2020. The document
announced the withdrawal of approval (as of June 15, 2020) of 16 new
drug applications (NDAs) from multiple applicants. The document
indicated that FDA was withdrawing approval of NDA 050641, Monodox
(doxycycline monohydrate) Capsules, Equivalent to (EQ) 50 milligrams
(mg) base, EQ 75 mg base, and EQ 100 mg base, after receiving a
withdrawal request from Aqua Pharmaceuticals, LLC, 707 Eagleview Blvd.,
Suite 200, Exton, PA 19341. Before FDA withdrew the approval of NDA
050641, Aqua Pharmaceuticals, LLC, informed FDA that it did not want
the approval of the NDA withdrawn. Because Aqua Pharmaceuticals, LLC,
timely requested that approval of the NDA not be withdrawn, the
approval of NDA 050641 is still in effect.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of May 14, 2020 (85
FR 28950), appearing on page 28950 in FR Doc. 2020-10367, the following
correction is made:
On page 28951, in the table, the entry for NDA 050641 is removed.
Dated: August 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-19364 Filed 9-1-20; 8:45 am]
BILLING CODE 4164-01-P
