Teva Branded Pharmaceutical Products R and D, Inc., et al.; Withdrawal of Approval of 35 New Drug Applications, 75276-75278 [2022-26661]
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75276
Federal Register / Vol. 87, No. 235 / Thursday, December 8, 2022 / Notices
lotter on DSK11XQN23PROD with NOTICES1
Guidance for Industry.’’ The guidance
document provides blood
establishments that collect blood and
blood components with FDA’s
recommendations to reduce the risk of
TTM. The recommendations contained
in the guidance apply to the collection
of Whole Blood and blood components,
except Source Plasma. Blood
establishments are not required to assess
Source Plasma donors for malaria risk
(see 21 CFR 630.15(b)(8)).
To address the urgent and immediate
need for blood and blood components
during the Coronavirus Disease 2019
(COVID–19) public health emergency, in
April 2020 FDA issued revised
recommendations to reduce the risk of
TTM during the public health
emergency. The recommendations in
the April 2020 guidance were based on
the Agency’s evaluation of the available
scientific and epidemiological data on
malaria risk, and data on FDA-approved
pathogen reduction devices. FDA stated
in the April 2020 guidance that we
expected implementation of the revised
recommendations would not be
associated with any adverse effect on
the safety of the blood supply and that
early implementation of the
recommendations may help to address
significant blood shortages that occurred
as result of the COVID–19 public health
emergency. Further, the guidance
explained that we expected that the
recommendations set forth in the
revised guidance would continue to
apply outside the context of the COVID–
19 public health emergency, and that
FDA would replace the April 2020
guidance with an updated guidance that
incorporates any appropriate changes
based on public comments and our
experience with implementation.
Although the April 2020 guidance
stated that we intended to reissue the
guidance within 60 days following the
termination of the public health
emergency, we are not delaying this
issuance because the guidance
represents our current thinking on the
topic.
FDA is issuing this guidance for
immediate implementation in
accordance with our good guidance
practices regulation (10.115(g)(3))
without initially seeking prior comment
because the Agency has determined that
prior public participation is not feasible
or appropriate (see 10.115(g)(2) and
section 701(h)(1)(C)(i) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
371(h)(1)(C)(i))). Specifically, we are not
seeking prior comment because the
recommendations present a less
burdensome policy for reducing the risk
of transfusion-transmitted malaria that
is consistent with public health, and
interested parties have had the
opportunity to comment on the
recommendations in the April 2020
guidance. The recommendations, which
are unchanged from the April 2020
guidance, will remain in effect outside
of the context of the public health
emergency related to COVID–19.
In the Federal Register of June 17,
2020 (85 FR 36598), FDA announced the
availability of the final guidance
entitled ‘‘Revised Recommendations to
Reduce the Risk of TransfusionTransmitted Malaria; Guidance for
Industry’’ dated April 2020. FDA
received no comments on the final
guidance.
The guidance represents the current
thinking of FDA on ‘‘Recommendations
to Reduce the Risk of TransfusionTransmitted Malaria.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 601 and
Form FDA 356h have been approved
under OMB control number 0910–0338;
21 CFR parts 606 and 630 have been
approved under OMB control number
0910–0116; and the collections of
information for consignee and
transfusion recipient physician
notification have been approved under
OMB control number 0910–0681.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: December 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–26711 Filed 12–7–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–3012]
Teva Branded Pharmaceutical
Products R and D, Inc., et al.;
Withdrawal of Approval of 35 New
Drug Applications
AGENCY:
ACTION:
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 35 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
January 9, 2023.
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:
Drug
NDA 006536 ................
Urecholine (bethanechol chloride) Injection, 5 milligram (mg)/milliliter (mL) ............................
Urecholine (bethanechol chloride) Tablets, 5 mg, 10 mg, 25 mg, and 50 mg .........................
NDA 011707 ................
Opana (oxymorphone hydrochloride (HCl)) Injection, 1 mg/mL and 1.5 mg/mL .....................
17:36 Dec 07, 2022
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Notice.
SUMMARY:
Application No.
VerDate Sep<11>2014
Food and Drug Administration,
HHS.
Applicant
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Teva Branded Pharmaceutical Products R
and D, Inc., 145 Brandywine Pkwy., West
Chester, PA 19380.
Endo Pharmaceuticals, Inc., 1400 Atwater
Dr., Malvern, PA 19355.
08DEN1
75277
Federal Register / Vol. 87, No. 235 / Thursday, December 8, 2022 / Notices
Application No.
Drug
Applicant
NDA 012209 ................
Fluorouracil Injection, 500 mg/10 mL and 2.5 grams (g)/50 mL ..............................................
NDA 016772 ................
Resectisol in plastic container (mannitol) Solution for Irrigation, 5 g/100 mL ..........................
NDA 017354 ................
Loestrin Fe 1/20 (ethinyl estradiol and norethindrone acetate) Tablets, 0.02 mg/1 mg ..........
NDA 017355 ................
NDA 017716 ................
Loestrin Fe 1.5/30 (ethinyl estradiol and norethindrone acetate) Tablets, 0.03 mg/1.5 mg) ...
Ovcon-35 (ethinyl estradiol and norethindrone) 28-Day Tablets, 0.035 mg/0.4 mg ................
NDA 017875 ................
Loestrin 1.5/30 (ethinyl estradiol and norethindrone acetate) 21-Day Tablets, 0.03 mg/1.5
mg.
Loestrin 1/20 (ethinyl estradiol and norethindrone acetate) 21-Day Tablets, 0.02 mg/1 mg ...
Ovcon-35 (ethinyl estradiol and norethindrone) 21-Day Tablets, 0.035 mg/0.4 mg ................
Spectrum Pharmaceuticals, Inc., 157 Technology Dr., Irvine, CA 92618.
B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA 18109–9341.
Teva Branded Pharmaceutical Products R
and D, Inc.
Do.
Warner Chilcott Co., LLC, c/o Warner Chilcott
(U.S.) LLC, 100 Enterprise Dr., NJ 07866.
Teva Branded Pharmaceutical Products R
and D, Inc.
Do.
Warner Chilcott Co., LLC, c/o Warner Chilcott
(U.S.) LLC.
Nesher Pharmaceuticals USA, LLC, 13910
Saint Charles Rock Rd., Bridgeton, MO
63044.
Teva Branded Pharmaceutical Products R&D,
Inc.
GlaxoSmithKline LLC, 2929 Walnut St., Suite
1700, Philadelphia, PA 19104.
Watson Laboratories, Inc., an indirect, wholly
owned subsidiary of Teva Pharmaceuticals
USA, Inc., 400 Interpace Pkwy., Parsippany, NJ 07054.
Alcon Laboratories, Inc., 6201 South Freeway, Fort Worth, TX 76134–2099.
Hospira, Inc., 275 North Field Dr., Bldg. HI–
3S, Lake Forest, IL 60045.
Eisai, Inc., 155 Tice Blvd., Woodcliff Lake, NJ
07611.
Allergan Pharmaceuticals International Ltd., c/
o Allergan Sales, LLC, 5 Giralda Farms,
Madison, NJ 07940.
NDA 017876 ................
NDA 018127 ................
NDA 018238 ................
Micro-K (potassium chloride) Extended-release Capsules, 8 milliequivalents (mEQ) .............
Micro-K 10 (potassium chloride) Extended-release Capsules, 10 mEQ ..................................
NDA 018405 ................
Aygestin (norethindrone acetate) Tablets, 5 mg .......................................................................
NDA 018603 ................
NDA 018764 ................
Zovirax (acyclovir sodium) for Injection, equivalent to (EQ) 250 mg base/vial, EQ 500 mg
base/vial, and EQ 1 g base/vial.
Metronidazole Tablets, 250 mg and 500 mg ............................................................................
NDA 018796 ................
Pilopine HS (pilocarpine HCl) Ophthalmic Gel, 4% ..................................................................
NDA 019211 ................
Theophylline in Dextrose 5% in plastic containers, Injection, 4 mg/mL, 40 mg/100 mL, 80
mg/100 mL, 160 mg/100 mL, 200 mg/100 mL, 320 mg/100 mL, and 400 mg/100 mL.
Hexalen (altretamine) Capsules, 50 mg ...................................................................................
NDA 019926 ................
NDA 020130 ................
NDA 020667 ................
NDA 020713 ................
NDA 021200 ................
Mircette (ethinyl estradiol; desogestrel and ethinyl estradiol) Tablets, (yellow) Tablets, 0.01
mg ethinyl estradiol and (white) Tablets, 0.15 mg desogestrel and 0.02 mg ethinyl estradiol.
Rebetol (ribavirin) Capsules, 200 mg .......................................................................................
Rebetol (ribavirin) Capsules, 200 mg (comarketed as Rebetron Combination Therapy with
Interferon ALFA–2B, Recombinant (INTRON A)).
Zelnorm (tegaserod maleate) Tablets, EQ 2 mg base and EQ 6 mg base .............................
NDA 021546 ................
Rebetol (rivavirin) Oral Solution, 40 mg/mL ..............................................................................
NDA 021858 ................
Boniva (ibandronate sodium) Injection, EQ 3 mg base/3 mL ...................................................
NDA 021871 ................
Loestrin 24 Fe (ethinyl estradiol and norethindrone acetate tablets, 0.02 mg/1mg; and ferrous fumarate tablets, 75 mg).
Onsolis (fentanyl citrate) Buccal Film, EQ 0.2 mg base, EQ 0.4 mg base, EQ 0.6 mg base,
EQ 0.8 mg base, and EQ 1.2 mg base.
Lazanda (fentanyl citrate) Nasal Spray, EQ 0.1 mg base, EQ 0.3 mg base, and EQ 0.4 mg
base.
NDA 020903 ................
NDA 022266 ................
NDA 022569 ................
NDA 040024 ................
Dexferrum (ferric oxyhydroxide) Injection, EQ 50 mg iron/mL .................................................
NDA 202342 ................
Esomeprazole Strontium Delayed-release Capsules, 24.65 mg and 49.3 mg ........................
NDA 202788 ................
Subsys (fentanyl) Sublingual Spray, 0.1 mg, 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.2 mg, and
1.6 mg.
Adzenys ER (amphetamine) Extended-release Oral Suspension, EQ 1.25 mg base/mL .......
NDA 204325 ................
NDA 205637 ................
NDA 210045 ................
lotter on DSK11XQN23PROD with NOTICES1
Estrostep Fe (ethinyl estradiol and norethindrone acetate) Tablets, (white triangle) Tablets,
0.02 mg ethinyl estradiol and 1 mg norethindrone acetate; (white square) Tablets, 0.03
mg ethinyl estradiol and 1 mg norethindrone acetate; (white round) Tablets, 0.035 mg
ethinyl estradiol and 1 mg norethindrone acetate.
Estrostep 21 (ethinyl estradiol and norethindrone acetate) Tablets, (white triangle) Tablets,
0.02 mg ethinyl estradiol and 1 mg norethindrone acetate; (white square) Tablets, 0.03
mg ethinyl estradiol and 1 mg norethindrone acetate; and (white round) Tablets, 0.035
mg ethinyl estradiol and 1 mg norethindrone acetate.
Mirapex (pramipexole dihydrocholoride) Tablets, 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1
mg, 1.25 mg, and 1.5 mg.
NDA 211281 ................
NDA 212038 ................
VerDate Sep<11>2014
Bunavail (buprenorphine HCl and naloxone HCl) Buccal Film, EQ 2.1 mg base/EQ 0.3 mg
base, EQ 4.2 mg base/EQ 0.7 mg base, and EQ 6.3 mg base/EQ 1 mg base.
Consensi (amlodipine besylate and celecoxib) Tablets, EQ 2.5 mg base/200 mg, EQ 5 mg
base/200 mg, and EQ 10 mg base/200 mg.
Pizensy (lactitol) Oral Solution, 10 g .........................................................................................
Adhansia XR (methylphenidate HCl) Extended-release Capsules, 25 mg, 35 mg, 45 mg, 55
mg, 70 mg, and 85 mg.
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Boehringer Ingelheim Pharmaceuticals, Inc.,
900 Ridgebury Rd., P.O. Box 368,
Ridgefield, CT 06877.
Teva Branded Pharmaceutical Products R
and D, Inc.
Merck Sharp and Dohme Corp., a subsidiary
of Merck & Co., Inc., 126 East Lincoln
Ave., P.O. Box 2000, Rahway, NJ 07065.
Alfasigma USA, Inc., 550 Hills Dr., Suite
110B, Bedminster, NJ 07921.
Merck Sharp and Dohme Corp., a subsidiary
of Merck & Co., Inc.
Hoffmann La Roche Inc., c/o Genentech, Inc.,
1 DNA Way, South San Francisco, CA
94080–4900.
Teva Branded Pharmaceutical Products R
and D, Inc.
Adalvo Limited c/o Biotech Research Group,
3810 Gunn Highway, Tampa, FL 33618.
BTcP Pharma LLC, c/o West Therapeutic Development, LLC, 1033 Skokie Blvd., Suite
620, Northbrook, IL 60062.
American Regent, Inc., 5 Ramsey Rd., Shirley, NY 11967.
Belcher Pharmatech, LLC, 6911 Bryan Dairy
Rd., Suite 220, Largo, FL 33777.
BTcP Pharma LLC, c/o West Therapeutic Development, LLC.
Neos Therapeutics Brands, Inc., 2940 N
Highway 360, Suite 400, Grand Prairie, TX
75050.
BioDelivery Sciences International, Inc., 4131
Park Lake Ave., Raleigh, NC 27612.
Purple Biotech LTD, 2520 Meridian Pkwy.,
Suite 200, Durham, NC 27713.
Braintree Laboratories, Inc., 60 Columbian St.
West, Braintree, MA 02184.
Purdue Pharma L.P., One Stamford Forum,
201 Tresser Blvd., Stamford, CT 06901–
3431.
08DEN1
75278
Federal Register / Vol. 87, No. 235 / Thursday, December 8, 2022 / Notices
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of January 9,
2023. Approval of each entire
application is withdrawn, including any
strengths and dosage forms included in
the application but 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 January 9, 2023 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: December 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–26661 Filed 12–7–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–P–0585]
Determination That NORFLEX
(Orphenadrine Citrate) Injection, 30
Milligrams/Milliliter, and NORFLEX
(Orphenadrine Citrate) ExtendedRelease Tablet, 100 Milligrams, Were
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
has determined that NORFLEX
(orphenadrine citrate) Injection, 30
milligrams (mg)/milliliter (mL), and
NORFLEX (orphenadrine citrate)
Extended-Release Tablet, 100 mg, were
not withdrawn from sale for reasons of
safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Anuj Shah, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:36 Dec 07, 2022
Jkt 259001
Ave., Bldg. 51, Rm. 6224, Silver Spring,
MD 20993–0002, 301–796–2246,
Anuj.Shah@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
FDA’s approval of an ANDA that refers
to the listed drug (§ 314.161 (21 CFR
314.161)). FDA may not approve an
ANDA that does not refer to a listed
drug.
NORFLEX (orphenadrine citrate)
Injection, 30 mg/mL, is the subject of
NDA 013055, held by Pai Holdings LLC
DBA Pharmaceutical Associates Inc.,
and initially approved on October 2,
1960. NORFLEX (orphenadrine citrate)
Extended-Release Tablet, 100 mg, is the
subject of NDA 012157, held by Bausch
Health US LLC, and initially approved
on November 2, 1959. Both NORFLEX
drug products are indicated as an
adjunct to rest, physical therapy, and
other measures for the relief of
discomfort associated with acute painful
musculoskeletal conditions.
Both NORFLEX (orphenadrine citrate)
Injection, 30 mg/mL, and NORFLEX
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(orphenadrine citrate) Extended-Release
Tablet, 100 mg, are currently listed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Odin Pharmaceuticals, LLC,
submitted a citizen petition dated April
11, 2022 (Docket No. FDA–2022–P–
0585), under 21 CFR 10.30, requesting
that the Agency determine whether
NORFLEX (orphenadrine citrate)
Injection, 30 mg/mL, was withdrawn
from sale for reasons of safety or
effectiveness. Although the citizen
petition did not address the 100 mg
extended-release tablet, that dosage
form and strength has also been
discontinued. On our own initiative, we
have also determined whether that
dosage form and strength was
withdrawn for safety or effectiveness
reasons.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that NORFLEX (orphenadrine
citrate) Injection, 30 mg/mL, and
NORFLEX (orphenadrine citrate)
Extended-Release Tablet, 100 mg, were
not withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that these drug products
were withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of NORFLEX
(orphenadrine citrate) Injection, 30 mg/
mL, and NORFLEX (orphenadrine
citrate) Extended-Release Tablet, 100
mg, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that these drug products were
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list NORFLEX
(orphenadrine citrate) Injection, 30 mg/
mL, and NORFLEX (orphenadrine
citrate) Extended-Release Tablet, 100
mg, in the ‘‘Discontinued Drug Product
List’’ section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
E:\FR\FM\08DEN1.SGM
08DEN1
]]>Agencies
[Federal Register Volume 87, Number 235 (Thursday, December 8, 2022)]
[Notices]
[Pages 75276-75278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26661]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-3012]
Teva Branded Pharmaceutical Products R and D, Inc., et al.;
Withdrawal of Approval of 35 New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 35 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 January 9, 2023.
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 006536................. Urecholine (bethanechol Teva Branded
chloride) Injection, 5 Pharmaceutical
milligram (mg)/ Products R and D,
milliliter (mL). Inc., 145
Urecholine (bethanechol Brandywine Pkwy.,
chloride) Tablets, 5 West Chester, PA
mg, 10 mg, 25 mg, and 19380.
50 mg.
NDA 011707................. Opana (oxymorphone Endo
hydrochloride (HCl)) Pharmaceuticals,
Injection, 1 mg/mL and Inc., 1400
1.5 mg/mL. Atwater Dr.,
Malvern, PA
19355.
[[Page 75277]]
NDA 012209................. Fluorouracil Injection, Spectrum
500 mg/10 mL and 2.5 Pharmaceuticals,
grams (g)/50 mL. Inc., 157
Technology Dr.,
Irvine, CA 92618.
NDA 016772................. Resectisol in plastic B. Braun Medical
container (mannitol) Inc., 901 Marcon
Solution for Blvd., Allentown,
Irrigation, 5 g/100 mL. PA 18109-9341.
NDA 017354................. Loestrin Fe 1/20 Teva Branded
(ethinyl estradiol and Pharmaceutical
norethindrone acetate) Products R and D,
Tablets, 0.02 mg/1 mg. Inc.
NDA 017355................. Loestrin Fe 1.5/30 Do.
(ethinyl estradiol and
norethindrone acetate)
Tablets, 0.03 mg/1.5
mg).
NDA 017716................. Ovcon-35 (ethinyl Warner Chilcott
estradiol and Co., LLC, c/o
norethindrone) 28-Day Warner Chilcott
Tablets, 0.035 mg/0.4 (U.S.) LLC, 100
mg. Enterprise Dr.,
NJ 07866.
NDA 017875................. Loestrin 1.5/30 Teva Branded
(ethinyl estradiol and Pharmaceutical
norethindrone acetate) Products R and D,
21-Day Tablets, 0.03 Inc.
mg/1.5 mg.
NDA 017876................. Loestrin 1/20 (ethinyl Do.
estradiol and
norethindrone acetate)
21-Day Tablets, 0.02
mg/1 mg.
NDA 018127................. Ovcon-35 (ethinyl Warner Chilcott
estradiol and Co., LLC, c/o
norethindrone) 21-Day Warner Chilcott
Tablets, 0.035 mg/0.4 (U.S.) LLC.
mg.
NDA 018238................. Micro-K (potassium Nesher
chloride) Extended- Pharmaceuticals
release Capsules, 8 USA, LLC, 13910
milliequivalents (mEQ). Saint Charles
Micro-K 10 (potassium Rock Rd.,
chloride) Extended- Bridgeton, MO
release Capsules, 10 63044.
mEQ.
NDA 018405................. Aygestin (norethindrone Teva Branded
acetate) Tablets, 5 mg. Pharmaceutical
Products R&D,
Inc.
NDA 018603................. Zovirax (acyclovir GlaxoSmithKline
sodium) for Injection, LLC, 2929 Walnut
equivalent to (EQ) 250 St., Suite 1700,
mg base/vial, EQ 500 Philadelphia, PA
mg base/vial, and EQ 1 19104.
g base/vial.
NDA 018764................. Metronidazole Tablets, Watson
250 mg and 500 mg. Laboratories,
Inc., an
indirect, wholly
owned subsidiary
of Teva
Pharmaceuticals
USA, Inc., 400
Interpace Pkwy.,
Parsippany, NJ
07054.
NDA 018796................. Pilopine HS Alcon
(pilocarpine HCl) Laboratories,
Ophthalmic Gel, 4%. Inc., 6201 South
Freeway, Fort
Worth, TX 76134-
2099.
NDA 019211................. Theophylline in Hospira, Inc., 275
Dextrose 5% in plastic North Field Dr.,
containers, Injection, Bldg. HI-3S, Lake
4 mg/mL, 40 mg/100 mL, Forest, IL 60045.
80 mg/100 mL, 160 mg/
100 mL, 200 mg/100 mL,
320 mg/100 mL, and 400
mg/100 mL.
NDA 019926................. Hexalen (altretamine) Eisai, Inc., 155
Capsules, 50 mg. Tice Blvd.,
Woodcliff Lake,
NJ 07611.
NDA 020130................. Estrostep Fe (ethinyl Allergan
estradiol and Pharmaceuticals
norethindrone acetate) International
Tablets, (white Ltd., c/o
triangle) Tablets, Allergan Sales,
0.02 mg ethinyl LLC, 5 Giralda
estradiol and 1 mg Farms, Madison,
norethindrone acetate; NJ 07940.
(white square)
Tablets, 0.03 mg
ethinyl estradiol and
1 mg norethindrone
acetate; (white round)
Tablets, 0.035 mg
ethinyl estradiol and
1 mg norethindrone
acetate.
Estrostep 21 (ethinyl
estradiol and
norethindrone acetate)
Tablets, (white
triangle) Tablets,
0.02 mg ethinyl
estradiol and 1 mg
norethindrone acetate;
(white square)
Tablets, 0.03 mg
ethinyl estradiol and
1 mg norethindrone
acetate; and (white
round) Tablets, 0.035
mg ethinyl estradiol
and 1 mg norethindrone
acetate.
NDA 020667................. Mirapex (pramipexole Boehringer
dihydrocholoride) Ingelheim
Tablets, 0.125 mg, Pharmaceuticals,
0.25 mg, 0.5 mg, 0.75 Inc., 900
mg, 1 mg, 1.25 mg, and Ridgebury Rd.,
1.5 mg. P.O. Box 368,
Ridgefield, CT
06877.
NDA 020713................. Mircette (ethinyl Teva Branded
estradiol; desogestrel Pharmaceutical
and ethinyl estradiol) Products R and D,
Tablets, (yellow) Inc.
Tablets, 0.01 mg
ethinyl estradiol and
(white) Tablets, 0.15
mg desogestrel and
0.02 mg ethinyl
estradiol.
NDA 020903................. Rebetol (ribavirin) Merck Sharp and
Capsules, 200 mg. Dohme Corp., a
Rebetol (ribavirin) subsidiary of
Capsules, 200 mg Merck & Co.,
(comarketed as Inc., 126 East
Rebetron Combination Lincoln Ave.,
Therapy with P.O. Box 2000,
Interferon ALFA-2B, Rahway, NJ 07065.
Recombinant (INTRON
A)).
NDA 021200................. Zelnorm (tegaserod Alfasigma USA,
maleate) Tablets, EQ 2 Inc., 550 Hills
mg base and EQ 6 mg Dr., Suite 110B,
base. Bedminster, NJ
07921.
NDA 021546................. Rebetol (rivavirin) Merck Sharp and
Oral Solution, 40 mg/ Dohme Corp., a
mL. subsidiary of
Merck & Co., Inc.
NDA 021858................. Boniva (ibandronate Hoffmann La Roche
sodium) Injection, EQ Inc., c/o
3 mg base/3 mL. Genentech, Inc.,
1 DNA Way, South
San Francisco, CA
94080-4900.
NDA 021871................. Loestrin 24 Fe (ethinyl Teva Branded
estradiol and Pharmaceutical
norethindrone acetate Products R and D,
tablets, 0.02 mg/1mg; Inc.
and ferrous fumarate
tablets, 75 mg).
NDA 022266................. Onsolis (fentanyl Adalvo Limited c/o
citrate) Buccal Film, Biotech Research
EQ 0.2 mg base, EQ 0.4 Group, 3810 Gunn
mg base, EQ 0.6 mg Highway, Tampa,
base, EQ 0.8 mg base, FL 33618.
and EQ 1.2 mg base.
NDA 022569................. Lazanda (fentanyl BTcP Pharma LLC, c/
citrate) Nasal Spray, o West
EQ 0.1 mg base, EQ 0.3 Therapeutic
mg base, and EQ 0.4 mg Development, LLC,
base. 1033 Skokie
Blvd., Suite 620,
Northbrook, IL
60062.
NDA 040024................. Dexferrum (ferric American Regent,
oxyhydroxide) Inc., 5 Ramsey
Injection, EQ 50 mg Rd., Shirley, NY
iron/mL. 11967.
NDA 202342................. Esomeprazole Strontium Belcher
Delayed-release Pharmatech, LLC,
Capsules, 24.65 mg and 6911 Bryan Dairy
49.3 mg. Rd., Suite 220,
Largo, FL 33777.
NDA 202788................. Subsys (fentanyl) BTcP Pharma LLC, c/
Sublingual Spray, 0.1 o West
mg, 0.2 mg, 0.4 mg, Therapeutic
0.6 mg, 0.8 mg, 1.2 Development, LLC.
mg, and 1.6 mg.
NDA 204325................. Adzenys ER Neos Therapeutics
(amphetamine) Extended- Brands, Inc.,
release Oral 2940 N Highway
Suspension, EQ 1.25 mg 360, Suite 400,
base/mL. Grand Prairie, TX
75050.
NDA 205637................. Bunavail (buprenorphine BioDelivery
HCl and naloxone HCl) Sciences
Buccal Film, EQ 2.1 mg International,
base/EQ 0.3 mg base, Inc., 4131 Park
EQ 4.2 mg base/EQ 0.7 Lake Ave.,
mg base, and EQ 6.3 mg Raleigh, NC
base/EQ 1 mg base. 27612.
NDA 210045................. Consensi (amlodipine Purple Biotech
besylate and LTD, 2520
celecoxib) Tablets, EQ Meridian Pkwy.,
2.5 mg base/200 mg, EQ Suite 200,
5 mg base/200 mg, and Durham, NC 27713.
EQ 10 mg base/200 mg.
NDA 211281................. Pizensy (lactitol) Oral Braintree
Solution, 10 g. Laboratories,
Inc., 60
Columbian St.
West, Braintree,
MA 02184.
NDA 212038................. Adhansia XR Purdue Pharma
(methylphenidate HCl) L.P., One
Extended-release Stamford Forum,
Capsules, 25 mg, 35 201 Tresser
mg, 45 mg, 55 mg, 70 Blvd., Stamford,
mg, and 85 mg. CT 06901-3431.
------------------------------------------------------------------------
[[Page 75278]]
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
January 9, 2023. Approval of each entire application is withdrawn,
including any strengths and dosage forms included in the application
but 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 January 9, 2023 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: December 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26661 Filed 12-7-22; 8:45 am]
BILLING CODE 4164-01-P
