[Federal Register Volume 87, Number 157 (Tuesday, August 16, 2022)]
[Notices]
[Pages 50337-50339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17534]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1728]
AbbVie Inc., et al.; Withdrawal of Approval of 30 New Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 30 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applications be withdrawn.
DATES: Approval is withdrawn as of September 15, 2022.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.
[[Page 50338]]
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Application No. Drug Applicant
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NDA 005856................ Tridione (trimethadione) AbbVie Inc., 1
Tablets, 150 milligrams North Waukegan
(mg); Tridione Rd., North
(trimethadione) Chicago, IL
Capsules, 300 mg; 60064.
Tridione
(trimethadione) Oral
Solution, 200 mg/5
milliliters (mL).
NDA 010679................ Cantil (mepenzolate Sanofi-Aventis
bromide) Tablets, 25 U.S., LLC, 55
mg; Cantil (mepenzolate Corporate Dr.,
bromide) Solution, 25 Bridgewater, NJ
mg/5 mL. 08807.
NDA 016042................ Dyazide GlaxoSmithKline
(hydrochlorothiazide/ LLC, 5 Crescent
triamterene) Capsules, Dr.,
25 mg/37.5 mg and 25 mg/ Philadelphia, PA
50 mg. 19112.
NDA 017531................ Tigan (trimethobenzamide King
hydrochloride (HCl)) Pharmaceuticals
Capsules, 300 mg. LLC, 235 East
42nd St., New
York, NY 10017.
NDA 017565................ Norinyl 1+ 35 (ethinyl Allergan Sales,
estradiol and LLC, 5 Giralda
norethindrone) Tablets, Farms, Madison,
0.035 mg/1 mg. NJ 07940.
NDA 017766................ NephrAmine 5.4% (amino B. Braun Medical
acids) Injection, 5.4% Inc., 901 Marcon
(5.4 grams (g)/100 mL). Blvd., Allentown,
PA 18109.
NDA 018053................ Bupivacaine HCl Hospira, Inc., 275
Injection, 0.25%, 0.5%, North Field Dr.,
and 0.75%. Bldg. H1-3S, Lake
Forest, IL 60045.
NDA 019558................ Prinivil (lisinopril) Merck Sharp &
Tablets, 2.5 mg, 5 mg, Dohme Corp., a
10 mg, 20 mg, and 40 mg. subsidiary of
Merck & Co.,
Inc., 1 Merck
Dr., Whitehouse
Station, NJ 08889-
0100.
NDA 019805................ Heparin Sodium in 5% Hospira, Inc.
Dextrose Injection,
4,000 Units/100 mL and
5,000 Units/100 mL.
NDA 019813................ Duragesic (fentanyl Janssen Research &
transdermal system) Development, LLC,
Extended-release Film, 1000 U.S. Route
12.5 micrograms (mcg)/ 202, Raritan, NJ
hour, 25 mcg/hour, 37.5 08869.
mcg/hour, 50 mcg/hour,
75 mcg/hour, and 100
mcg/hour.
NDA 019917................ Morphine Sulfate ICU Medical, Inc.,
Injection, 0.5 mg/mL. 600 N. Field Dr.,
Lake Forest, IL
60045.
NDA 020156................ Videx (didanosine) Bristol-Myers
Powder for Oral Squibb Co., P.O.
Solution, 10 mg/mL. Box 4000,
Princeton, NJ
08543-4000.
NDA 020570................ Quadramet (samarium sm Lantheus Medical
153 lexidronam Imaging, Inc.,
pentasodium) Injection, 331 Treble Cove
50 millicuries/mL. Rd., Bldg. 300-2,
North Billerica,
MA 01862.
NDA 020591................ Tarka (trandolapril and AbbVie Inc.
verapamil HCl) Extended-
release Tablets, 1 mg/
240 mg, 2 mg/180 mg, 2
mg/240 mg, and 4 mg/240
mg.
NDA 020658................ Requip (ropinirole HCl) GlaxoSmithKline
Tablets, equivalent to LLC.
(EQ) 0.25 mg base, EQ
0.5 mg base, EQ 1 mg
base, EQ 2 mg base, EQ
3 mg base, EQ 4 mg
base, and EQ 5 mg base.
NDA 020685................ Crixivan (indinavir Merck Sharp &
sulfate) Capsules, EQ Dohme Corp.
100 mg base, EQ 200 mg
base, EQ 333 mg base,
and EQ 400 mg base.
NDA 020732................ Subutex (buprenorphine Indivior Inc.,
HCl), sublingual 10710 Midlothian
tablets, EQ 2mg base Turnpike, Suite
and EQ 8mg base. 125, North
Chesterfield, VA
23235.
NDA 020733................ Suboxone (buprenorphine Do.
HCl and naloxone HCl)
Sublingual Tablets, EQ
2 mg base/EQ 0.5 mg
base, and EQ 8 mg base/
EQ 2 mg base.
NDA 020946................ Preven Emergency Teva Branded
Contraceptive Kit Pharmaceutical
(ethinyl estradiol and Products R&D,
levonorgestrel) Inc., 145
Tablets, 0.05 mg/0.25 Brandywine Pkwy.,
mg. West Chester, PA
19380.
NDA 021183................ Videx EC (didanosine) Bristol-Myers
Delayed-release Squibb Co.
Capsules, 125 mg, 200
mg, 250 mg, and 400 mg.
NDA 021627................ Namenda (memantine HCl) Allergan Sales,
Oral Solution, 2 mg/mL. LLC.
NDA 022008................ Requip XL (ropinirole GlaxoSmithKline
HCl) Extended-release LLC.
Tablets, EQ 2 mg base,
EQ 3 mg base, EQ 4 mg
base, EQ 6 mg base, EQ
8 mg base, and EQ 12 mg
base.
NDA 022205................ Giazo (balsalazide Salix
disodium) Tablets, 1.1 Pharmaceuticals,
g. Inc., 400
Somerset
Corporate Blvd.,
Bridgewater, NJ
08807.
NDA 022246................ Metozolv ODT Do.
(metoclopramide HCl)
Orally Disintegrating
Tablets, EQ 5 mg base
and EQ 10 mg base.
NDA 022401................ Twynsta (amlodipine Boehringer
besylate and Ingelheim
telmisartan) Tablets, Pharmaceuticals,
EQ 5 mg base/40 mg, EQ Inc., 900
5 mg base/80 mg, EQ 10 Ridgebury Rd.,
mg base/40 mg, and EQ P.O. Box 368,
10 mg base/80 mg. Ridgefield, CT
06877.
NDA 050662................ Biaxin Filmtab AbbVie Inc.
(clarithromycin,)
Tablets, 250 mg and 500
mg.
NDA 050698................ Biaxin Granules for Oral Do.
Suspension
(clarithromycin) 125 mg/
5 mL, 187 mg/5 mL, and
250 mg/5 mL.
NDA 050775................ Biaxin XL Filmtab Do.
(clarithromycin)
Extended-release
Tablets, 500 mg.
NDA 209305................ Eskata (hydrogen Aclaris
peroxide) Topical Therapeutics,
Solution, 40%. Inc., 640 Lee
Rd., Suite 200,
Wayne, PA 19087.
NDA 211210................ Qmiiz ODT (meloxicam) TerSera
Orally Disintegrating Therapeutics LLC,
Tablets, 7.5 mg and 15 520 Lake Cook
mg. Rd., Suite 500,
Deerfield, IL
60015.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
September 15, 2022. 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 September 15, 2022 may
continue to be dispensed until the
[[Page 50339]]
inventories have been depleted or the drug products have reached their
expiration dates or otherwise become violative, whichever occurs first.
Dated: August 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17534 Filed 8-15-22; 8:45 am]
BILLING CODE 4164-01-P