Hikma Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 29 New Drug Applications, 5827-5828 [2022-02059]
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Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Notices
will take respondents, collectively,
1,080 hours to gather, copy, and submit
brief statements about the product, a
description of the details of the
anticipated meeting, and data and
information, including identifying prior
FDA submissions for the product or
relevant versions of the product, that
generally would already have been
generated for the planned research and/
or product development.
The total number of burden hours for
this collection of information is
estimated to be 1,680 hours (600 hours
to prepare and submit meeting requests
and 1,080 hours to prepare and submit
information packages). Our estimated
burden for the information collection
reflects an overall decrease of 644 hours.
We attribute this adjustment to a
decrease in the number of submissions
we received over the last few years and
our projections for the next 3 years.
[FR Doc. 2022–02055 Filed 2–1–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0079]
Hikma Pharmaceuticals USA, Inc., et
al.; Withdrawal of Approval of 29 New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 29 new drug
applications (NDAs) from multiple
applicants. The applicants notified the
Agency in writing that the drug
SUMMARY:
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of
March 4, 2022.
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.
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.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
NDA 006134 ........................
Hikma Pharmaceuticals USA, Inc., 1809 Wilson Rd.,
Columbus, OH 43228.
NDA 006882 ........................
Dolophine (methadone hydrochloride (HCl)) Tablets, 5
milligrams (mg), and 10 mg.
Dolophine (methadone HCl) Syrup, 10 mg/30 milliliter
(mL).
Phisohex (hexachlorophene) Emulsion, 3% ...................
NDA 009818 ........................
Kemadrin (procyclidine HCl) Tablets, 2 mg, and 5 mg ..
NDA 012301 ........................
Librium (chlordiazepoxide HCl), Injection, 100 mg/ampule.
Norgesic (orphenadrine citrate, aspirin, and caffeine)
Tablets, 25 mg/385 mg/30 mg.
Norgesic Forte (orphenadrine citrate, aspirin, and caffeine) Tablets, 50 mg/770 mg/60 mg.
Spandin (aspirin and sodium salicylate) Time-released
Tablets, 7.5 grains/2.5 grains.
Talwin (pentazocine lactate) Injection, equivalent to
(EQ) 30 mg base/mL.
Inderal (propranolol HCl) Tablets, 10 mg, 20 mg, 40
mg, 60 mg, 80 mg, and 90 mg.
Resectisol (mannitol) Irrigation Solution, 5 grams (g)/
100 mL.
Inderal (propranolol HCl) Tablets, 10 mg, 20 mg, 40
mg, 60 mg, and 80 mg.
Micronor (norethindrone) Tablets, 0.35 mg ....................
NDA 013416 ........................
NDA 014228 ........................
NDA 016194 ........................
NDA 016418 ........................
NDA 016704 ........................
NDA 016762 ........................
NDA 016954 ........................
NDA 017013 ........................
NDA 017683 ........................
NDA 018423 ........................
jspears on DSK121TN23PROD with NOTICES1
Dated: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
5827
Sodium Chloride Injection, 20 g/100 mL ........................
Inderal (propranolol HCL) Tablets, 10 mg, 20 mg, 40
mg, 60 mg, and 80 mg.
Hibiclens (chlorhexidine gluconate) Sponge, 4% ...........
NDA 018703 ........................
Zantac (ranitidine HCl) Tablets, EQ 150 mg base, and
EQ 300 mg base.
NDA 019387 ........................
Profenal (suprofen) Ophthalmic Solution, 1% ................
NDA 019530 ........................
NDA 019675 ........................
Ucephan (sodium benzoate and sodium phenylacetate)
Solution, 100 mg/mL; 100 mg/mL.
Zantac (ranitidine HCl) Syrup, EQ 15 mg base/mL ........
NDA 019814 ........................
NDA 019927 ........................
Betagan (levobunolol HCl) Ophthalmic Solution, 0.25%
Nizoral (ketoconazole) Shampoo, 2% ............................
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Sanofi-aventis U.S. LLC, 55 Corporate Dr., Bridgewater, NJ 08807.
Monarch Pharmaceuticals, LLC, c/o Pfizer, Inc., 235
East 42nd St., New York, NY 10017.
Bausch Health US, LLC, 400 Somerset Corporate
Blvd., Bridgewater, NJ 08807.
Bausch Health US, LLC.
Abbott Healthcare Pvt. Ltd., c/o G&L Scientific, Independence Blvd., 4th Floor, Warren, NJ 07059.
Hospira Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045.
Wyeth Pharmaceuticals LLC, 235 E. 42nd St., New
York, NY 10017.
B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA
18109.
Wyeth Pharmaceuticals LLC.
Janssen Pharmaceuticals, Inc., 1125 TrentonHarbourton Rd., Titusville, NJ 08560.
Abbott Healthcare Pvt. Ltd., c/o G&L Scientific.
Wyeth Pharmaceuticals LLC.
Mo¨lnlycke Health Care, 5445 Triangle Pkwy., Suite
400, Peachtree Corners, GA 30092.
GlaxoSmithKline Intellectual Property Ltd. England, c/o
GlaxoSmithKline, 5 Crescent Dr., Philadelphia, PA
19112.
Alcon Laboratories, Inc., 6201 South Freeway, Fort
Worth, TX 76134–2099.
B. Braun Medical Inc.
GlaxoSmithKline Intellectual Property Ltd. England, c/o
GlaxoSmithKline.
Allergan, Inc.
Janssen Pharmaceuticals, Inc.
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5828
Federal Register / Vol. 87, No. 22 / Wednesday, February 2, 2022 / Notices
Application No.
Drug
Applicant
NDA 020037 ........................
Voltaren (diclofenac sodium) Ophthalmic Solution, 0.1%
NDA 021169 ........................
Razadyne (galantamine hydrobromide) Tablets, EQ 4
mg base, EQ 8 mg base, and EQ 12 mg base.
Starlix (nateglinide) Tablets, 60 mg, and 120 mg ..........
Fortical (calcitonin-salmon recombinant) Nasal Spray,
200 International Units/Spray.
Sarafem (fluoxetine HCl) Tablets, EQ 10 mg base, EQ
15 mg base, and EQ 20 mg base.
Novartis Pharmaceuticals Corp., 1 Health Plaza, East
Hanover, NJ 07936–1080.
Janssen Research & Development, LLC, 1125 TrentonHarbourton Rd., Titusville, NJ 08560.
Novartis Pharmaceuticals Corp.
Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr.,
Maple Grove, MN 55369.
Allergan Pharmaceuticals International Ltd., c/o
Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ
07940.
LEO Laboratories Ltd., c/o LEO Pharma Inc., 7 Giralda
Farms, Madison, NJ 07940.
Recro Gainesville LLC, 1300 Gould Dr., Gainesville,
GA 30504.
NDA 021204 ........................
NDA 021406 ........................
NDA 021860 ........................
NDA 202833 ........................
Picato (ingenol mebutate) Gel, 0.015%, and 0.05% ......
NDA 202880 ........................
Zohydro ER (hydrocodone bitartrate) Extended-release
Capsules, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and
50 mg.
Khedezla (desvenlafaxine) Extended-Release Tablets,
50 mg, and 100 mg.
Cetylev (acetylcysteine) Effervescent Tablets, 500 mg,
and 2.5 g.
NDA 204683 ........................
NDA 207916 ........................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of March 4,
2022. 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 March 4, 2022
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0074]
Watson Laboratories, Inc., et al.;
Withdrawal of Approval of Eight
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Dated: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of eight
abbreviated new drug applications
(ANDAs) 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.
[FR Doc. 2022–02059 Filed 2–1–22; 8:45 am]
DATES:
BILLING CODE 4164–01–P
jspears on DSK121TN23PROD with NOTICES1
Osmotica Pharmaceutical US LLC, 400 Crossing Blvd.,
Bridgewater, NJ 08807.
Arbor Pharmaceuticals, LLC, 6 Concourse Pkwy., Suite
1800, Atlanta, GA 30328.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
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
described 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.
SUPPLEMENTARY INFORMATION:
Approval is withdrawn as of
March 4, 2022.
Application No.
Drug
Applicant
ANDA 075152 ........
Diclofenac Potassium Tablets, 50 milligrams (mg) ................
ANDA 091376 ........
ANDA 091471 ........
Topotecan Hydrochloride (HCl) for Injection, Equivalent to
(EQ) 4 mg base/vial.
Efavirenz Tablets, 600 mg .....................................................
ANDA 200463 ........
Itraconazole Capsules, 100 mg .............................................
ANDA 202395 ........
ANDA 203170 ........
Ziprasidone HCl Capsules, EQ 20 mg base, EQ 40 mg
base, EQ 60 mg base, and EQ 80 mg base.
Docetaxel Injection, 40 mg/milliliter ........................................
Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace
Pkwy., Bldg. A, Parsippany, NJ 07054.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
Mylan Pharmaceuticals Inc., a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505.
Mylan Pharmaceuticals Inc., a Viatris Company, 781 Chestnut Ridge Rd., Morgantown, WV 26504.
Do.
ANDA 203574 ........
Mesalamine Delayed Release Tablets, 1.2 grams ................
ANDA 208177 ........
Atazanavir Sulfate Capsules, EQ 150 mg base, EQ 200 mg
base, and EQ 300 mg base.
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Jiangsu Hengrui Pharmaceuticals Co., Ltd., U.S. Agent,
eVenus Pharmaceutical Laboratories Inc., 506 Carnegie
Center, Suite 100, Princeton, NJ 08540.
Mylan Pharmaceuticals Inc., a Viatris Company, 781 Chestnut Ridge Rd., Morgantown, WV 26504.
Do.
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]]>Agencies
[Federal Register Volume 87, Number 22 (Wednesday, February 2, 2022)]
[Notices]
[Pages 5827-5828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02059]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0079]
Hikma Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval
of 29 New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 29 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 March 4, 2022.
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: 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 006134.................. Dolophine (methadone Hikma
hydrochloride Pharmaceuticals
(HCl)) Tablets, 5 USA, Inc., 1809
milligrams (mg), Wilson Rd.,
and 10 mg. Columbus, OH 43228.
Dolophine (methadone
HCl) Syrup, 10 mg/
30 milliliter (mL).
NDA 006882.................. Phisohex Sanofi-aventis U.S.
(hexachlorophene) LLC, 55 Corporate
Emulsion, 3%. Dr., Bridgewater,
NJ 08807.
NDA 009818.................. Kemadrin Monarch
(procyclidine HCl) Pharmaceuticals,
Tablets, 2 mg, and LLC, c/o Pfizer,
5 mg. Inc., 235 East 42nd
St., New York, NY
10017.
NDA 012301.................. Librium Bausch Health US,
(chlordiazepoxide LLC, 400 Somerset
HCl), Injection, Corporate Blvd.,
100 mg/ampule. Bridgewater, NJ
08807.
NDA 013416.................. Norgesic Bausch Health US,
(orphenadrine LLC.
citrate, aspirin,
and caffeine)
Tablets, 25 mg/385
mg/30 mg.
Norgesic Forte
(orphenadrine
citrate, aspirin,
and caffeine)
Tablets, 50 mg/770
mg/60 mg.
NDA 014228.................. Spandin (aspirin and Abbott Healthcare
sodium salicylate) Pvt. Ltd., c/o G&L
Time-released Scientific,
Tablets, 7.5 grains/ Independence Blvd.,
2.5 grains. 4th Floor, Warren,
NJ 07059.
NDA 016194.................. Talwin (pentazocine Hospira Inc., 275
lactate) Injection, North Field Dr.,
equivalent to (EQ) Bldg. H1, Lake
30 mg base/mL. Forest, IL 60045.
NDA 016418.................. Inderal (propranolol Wyeth
HCl) Tablets, 10 Pharmaceuticals
mg, 20 mg, 40 mg, LLC, 235 E. 42nd
60 mg, 80 mg, and St., New York, NY
90 mg. 10017.
NDA 016704.................. Resectisol B. Braun Medical
(mannitol) Inc., 901 Marcon
Irrigation Blvd., Allentown,
Solution, 5 grams PA 18109.
(g)/100 mL.
NDA 016762.................. Inderal (propranolol Wyeth
HCl) Tablets, 10 Pharmaceuticals
mg, 20 mg, 40 mg, LLC.
60 mg, and 80 mg.
NDA 016954.................. Micronor Janssen
(norethindrone) Pharmaceuticals,
Tablets, 0.35 mg. Inc., 1125 Trenton-
Harbourton Rd.,
Titusville, NJ
08560.
NDA 017013.................. Sodium Chloride Abbott Healthcare
Injection, 20 g/100 Pvt. Ltd., c/o G&L
mL. Scientific.
NDA 017683.................. Inderal (propranolol Wyeth
HCL) Tablets, 10 Pharmaceuticals
mg, 20 mg, 40 mg, LLC.
60 mg, and 80 mg.
NDA 018423.................. Hibiclens M[ouml]lnlycke
(chlorhexidine Health Care, 5445
gluconate) Sponge, Triangle Pkwy.,
4%. Suite 400,
Peachtree Corners,
GA 30092.
NDA 018703.................. Zantac (ranitidine GlaxoSmithKline
HCl) Tablets, EQ Intellectual
150 mg base, and EQ Property Ltd.
300 mg base. England, c/o
GlaxoSmithKline, 5
Crescent Dr.,
Philadelphia, PA
19112.
NDA 019387.................. Profenal (suprofen) Alcon Laboratories,
Ophthalmic Inc., 6201 South
Solution, 1%. Freeway, Fort
Worth, TX 76134-
2099.
NDA 019530.................. Ucephan (sodium B. Braun Medical
benzoate and sodium Inc.
phenylacetate)
Solution, 100 mg/
mL; 100 mg/mL.
NDA 019675.................. Zantac (ranitidine GlaxoSmithKline
HCl) Syrup, EQ 15 Intellectual
mg base/mL. Property Ltd.
England, c/o
GlaxoSmithKline.
NDA 019814.................. Betagan (levobunolol Allergan, Inc.
HCl) Ophthalmic
Solution, 0.25%.
NDA 019927.................. Nizoral Janssen
(ketoconazole) Pharmaceuticals,
Shampoo, 2%. Inc.
[[Page 5828]]
NDA 020037.................. Voltaren (diclofenac Novartis
sodium) Ophthalmic Pharmaceuticals
Solution, 0.1%. Corp., 1 Health
Plaza, East
Hanover, NJ 07936-
1080.
NDA 021169.................. Razadyne Janssen Research &
(galantamine Development, LLC,
hydrobromide) 1125 Trenton-
Tablets, EQ 4 mg Harbourton Rd.,
base, EQ 8 mg base, Titusville, NJ
and EQ 12 mg base. 08560.
NDA 021204.................. Starlix Novartis
(nateglinide) Pharmaceuticals
Tablets, 60 mg, and Corp.
120 mg.
NDA 021406.................. Fortical (calcitonin- Upsher-Smith
salmon recombinant) Laboratories, LLC,
Nasal Spray, 200 6701 Evenstad Dr.,
International Units/ Maple Grove, MN
Spray. 55369.
NDA 021860.................. Sarafem (fluoxetine Allergan
HCl) Tablets, EQ 10 Pharmaceuticals
mg base, EQ 15 mg International Ltd.,
base, and EQ 20 mg c/o Allergan Sales,
base. LLC, 5 Giralda
Farms, Madison, NJ
07940.
NDA 202833.................. Picato (ingenol LEO Laboratories
mebutate) Gel, Ltd., c/o LEO
0.015%, and 0.05%. Pharma Inc., 7
Giralda Farms,
Madison, NJ 07940.
NDA 202880.................. Zohydro ER Recro Gainesville
(hydrocodone LLC, 1300 Gould
bitartrate) Dr., Gainesville,
Extended-release GA 30504.
Capsules, 10 mg, 15
mg, 20 mg, 30 mg,
40 mg, and 50 mg.
NDA 204683.................. Khedezla Osmotica
(desvenlafaxine) Pharmaceutical US
Extended-Release LLC, 400 Crossing
Tablets, 50 mg, and Blvd., Bridgewater,
100 mg. NJ 08807.
NDA 207916.................. Cetylev Arbor
(acetylcysteine) Pharmaceuticals,
Effervescent LLC, 6 Concourse
Tablets, 500 mg, Pkwy., Suite 1800,
and 2.5 g. Atlanta, GA 30328.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of March
4, 2022. 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 March 4, 2022 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: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02059 Filed 2-1-22; 8:45 am]
BILLING CODE 4164-01-P
