Allergan Sales, LLC, et al.; Withdrawal of Approval of 18 New Drug Applications, 60251-60252 [2021-23729]
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Federal Register / Vol. 86, No. 208 / Monday, November 1, 2021 / Notices
marketed in accordance with
requirements under section 505G of the
FD&C Act (21 U.S.C. 355h), often
referred to as over-the-counter
monograph drugs, and animal drug
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360ccc–1).
This draft guidance is being issued
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practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Reporting Amount of Listed Drugs
and Biological Products Under Section
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establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
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• FDA requires that applicants submit
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III. Electronic Access
Dated: October 27, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–23722 Filed 10–29–21; 8:45 am]
BILLING CODE 4164–01–P
Application No.
Drug
NDA 007409 ......
NDA 014169 ......
Bentyl (dicyclomine hydrochloride (HCl)) Capsules, 10 milligram (mg).
Bentyl (dicyclomine HCl) Tablets, 20 mg.
Norinyl 1 + 50 (norethindrone and mestranol) Tablets, 0.05
mg/1 mg.
Norinyl (norethindrone and mestranol) Tablets, 0.1 mg/2 mg
Dendrid (idoxuridine) Ophthalmic Solution, 0.1% ....................
NDA 019404 ......
NDA 019784 ......
Ocufen (flurbiprofen sodium) Ophthalmic Solution, 0.03% .....
Ibuprofen Oral Suspension, 100 mg/5 milliliters (mL) .............
NDA 020010 ......
Lotrisone (betamethasone dipropionate and clotrimazole) Lotion, Equivalent to (EQ) 0.05% base/1%.
NDA 020098 ......
Mivacron (mivacurium chloride) Solution, EQ 2 mg base/mL,
EQ 10 mg base/5 mL, and EQ 20 mg base/10 mL.
Mivacron in Dextrose 5% in plastic container (mivacurium
chloride) Injectable, EQ 0.5 mg base/mL and EQ 50 mg
base/100 mL.
Zerit (stavudine) Capsules, 5 mg, 15 mg, 20 mg, 30 mg, and
40 mg.
NDA 013625 ......
lotter on DSK11XQN23PROD with NOTICES1
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
NDA 020412 ......
VerDate Sep<11>2014
18:03 Oct 29, 2021
Jkt 256001
PO 00000
60251
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–1071]
Allergan Sales, LLC, et al.; Withdrawal
of Approval of 18 New Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 18 new drug
applications (NDAs) from multiple
applicants. The applicants 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
December 1, 2021.
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.
SUPPLEMENTARY INFORMATION: The
applicants 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:
Applicant
Frm 00054
Fmt 4703
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Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ 07940.
Actavis Laboratories UT, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 145 Brandywine Pkwy., West Chester, PA 19380.
Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth,
TX 76134.
Allergan, Inc., 2525 Dupont Dr., Irvine, CA 92612.
Abbott Laboratories Established Pharmaceuticals Products
Division, 200 Abbott Park Rd., Abbott Park, IL 60064.
Merck Sharp and Dohme Corp., a subsidiary of Merck and
Co., Inc., 1 Merck Drive, P.O. Box 100, Whitehouse Station, NJ 08889.
AbbVie, Inc., 1 N Waukegan Rd., North Chicago, IL 60064
Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ
08543.
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60252
Federal Register / Vol. 86, No. 208 / Monday, November 1, 2021 / Notices
Application No.
Drug
NDA 020509 ......
Gemzar (gemcitabine HCl) Injection, EQ 200 mg base and
EQ 1 gram (g) base.
Antizol (fomepizole) Injection, 1.5 g/1.5 mL ............................
NDA 020696 ......
NDA 020705 ......
NDA 021114 ......
NDA 021199 ......
NDA 021571 ......
NDA 050704 ......
NDA 204736 ......
NDA 205060 ......
NDA 206843 ......
Rescriptor (delavirdine mesylate) Tablets, 100 mg and 200
mg.
Betaxon (levobetaxolol HCl) Ophthalmic Suspension, EQ
0.5% base.
Quixin (levofloxacin) Ophthalmic Solution, 0.5% .....................
Iquix (levofloxacin) Ophthalmic Solution, 1.5% .......................
DaunoXome (daunorubicin citrate liposome injection), EQ 2
mg base/mL.
AcipHex Sprinkle (rabeprazole sodium) Delayed Release
Capsules, 5 mg and 10 mg.
Epanova (omega-3-carboxylic acids) Capsules, 1 gram (1 g
contains at least 850 mg of polyunsaturated fatty acids).
Daklinza (daclatasvir dihydrochloride) Tablets, EQ 30 mg
base, EQ 60 mg base, and EQ 90 mg base.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of December 1,
2021. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
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 December 1,
2021 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: October 25, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–23729 Filed 10–29–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–E–1817; FDA–
2020–E–1818; FDA–2020–E–1820]
lotter on DSK11XQN23PROD with NOTICES1
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ENHERTU
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for ENHERTU and is publishing this
SUMMARY:
VerDate Sep<11>2014
Applicant
18:03 Oct 29, 2021
Jkt 256001
Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN
46285.
Par Sterile Products, LLC, 6 Ram Ridge Rd., Chestnut
Ridge, NY 10977.
ViiV Healthcare Co., 5 Moore Dr., Research Triangle Park,
NC 27709.
Alcon Laboratories, Inc.
Santen Inc., 6401 Hollis St., Suite 125, Emeryville, CA
94608.
Do.
Galen Limited, 25 Fretz Rd., Souderton, PA 18964.
Aytu BioScience Inc., 373 Inverness Parkway, Suite 206, Englewood, CO 80112.
AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, Wilmington, DE 19803.
Bristol-Myers Squibb Co.
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human
biological product.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by January 3, 2022.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
May 2, 2022. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 3,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 3, 2022. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
PO 00000
Frm 00055
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www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
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comments, that information will be
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• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2020–E–1817; FDA–2020–E–1818; and
FDA–2020–E–1820, for ‘‘Determination
of Regulatory Review Period for
Purposes of Patent Extension;
ENHERTU.’’ Received comments, those
filed in a timely manner (see
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]]>Agencies
[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Notices]
[Pages 60251-60252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23729]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1071]
Allergan Sales, LLC, et al.; Withdrawal of Approval of 18 New
Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 18 new drug applications (NDAs) from multiple
applicants. The applicants 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 December 1, 2021.
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.
SUPPLEMENTARY INFORMATION: The applicants 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 007409............. Bentyl (dicyclomine Allergan Sales, LLC, 5
hydrochloride (HCl)) Giralda Farms,
Capsules, 10 milligram Madison, NJ 07940.
(mg).
Bentyl (dicyclomine
HCl) Tablets, 20 mg.
NDA 013625............. Norinyl 1 + 50 Actavis Laboratories
(norethindrone and UT, Inc. (an
mestranol) Tablets, indirect, wholly
0.05 mg/1 mg. owned subsidiary of
Norinyl (norethindrone Teva Pharmaceuticals
and mestranol) USA, Inc.), 145
Tablets, 0.1 mg/2 mg. Brandywine Pkwy.,
West Chester, PA
19380.
NDA 014169............. Dendrid (idoxuridine) Alcon Laboratories,
Ophthalmic Solution, Inc., 6201 South
0.1%. Freeway, Fort Worth,
TX 76134.
NDA 019404............. Ocufen (flurbiprofen Allergan, Inc., 2525
sodium) Ophthalmic Dupont Dr., Irvine,
Solution, 0.03%. CA 92612.
NDA 019784............. Ibuprofen Oral Abbott Laboratories
Suspension, 100 mg/5 Established
milliliters (mL). Pharmaceuticals
Products Division,
200 Abbott Park Rd.,
Abbott Park, IL
60064.
NDA 020010............. Lotrisone Merck Sharp and Dohme
(betamethasone Corp., a subsidiary
dipropionate and of Merck and Co.,
clotrimazole) Lotion, Inc., 1 Merck Drive,
Equivalent to (EQ) P.O. Box 100,
0.05% base/1%. Whitehouse Station,
NJ 08889.
NDA 020098............. Mivacron (mivacurium AbbVie, Inc., 1 N
chloride) Solution, EQ Waukegan Rd., North
2 mg base/mL, EQ 10 mg Chicago, IL 60064
base/5 mL, and EQ 20
mg base/10 mL.
Mivacron in Dextrose 5%
in plastic container
(mivacurium chloride)
Injectable, EQ 0.5 mg
base/mL and EQ 50 mg
base/100 mL.
NDA 020412............. Zerit (stavudine) Bristol-Myers Squibb
Capsules, 5 mg, 15 mg, Co., P.O. Box 4000,
20 mg, 30 mg, and 40 Princeton, NJ 08543.
mg.
[[Page 60252]]
NDA 020509............. Gemzar (gemcitabine Eli Lilly and Co.,
HCl) Injection, EQ 200 Lilly Corporate
mg base and EQ 1 gram Center, Indianapolis,
(g) base. IN 46285.
NDA 020696............. Antizol (fomepizole) Par Sterile Products,
Injection, 1.5 g/1.5 LLC, 6 Ram Ridge Rd.,
mL. Chestnut Ridge, NY
10977.
NDA 020705............. Rescriptor (delavirdine ViiV Healthcare Co., 5
mesylate) Tablets, 100 Moore Dr., Research
mg and 200 mg. Triangle Park, NC
27709.
NDA 021114............. Betaxon (levobetaxolol Alcon Laboratories,
HCl) Ophthalmic Inc.
Suspension, EQ 0.5%
base.
NDA 021199............. Quixin (levofloxacin) Santen Inc., 6401
Ophthalmic Solution, Hollis St., Suite
0.5%. 125, Emeryville, CA
94608.
NDA 021571............. Iquix (levofloxacin) Do.
Ophthalmic Solution,
1.5%.
NDA 050704............. DaunoXome (daunorubicin Galen Limited, 25
citrate liposome Fretz Rd., Souderton,
injection), EQ 2 mg PA 18964.
base/mL.
NDA 204736............. AcipHex Sprinkle Aytu BioScience Inc.,
(rabeprazole sodium) 373 Inverness
Delayed Release Parkway, Suite 206,
Capsules, 5 mg and 10 Englewood, CO 80112.
mg.
NDA 205060............. Epanova (omega-3- AstraZeneca
carboxylic acids) Pharmaceuticals LP,
Capsules, 1 gram (1 g 1800 Concord Pike,
contains at least 850 Wilmington, DE 19803.
mg of polyunsaturated
fatty acids).
NDA 206843............. Daklinza (daclatasvir Bristol-Myers Squibb
dihydrochloride) Co.
Tablets, EQ 30 mg
base, EQ 60 mg base,
and EQ 90 mg base.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
December 1, 2021. Approval of each entire application is withdrawn,
including any strengths and dosage forms inadvertently missing from the
table. 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 December 1, 2021 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: October 25, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23729 Filed 10-29-21; 8:45 am]
BILLING CODE 4164-01-P
