Document ID: FDA-2022-N-1728-0001
Agency: fda
Document Type: Notice
Title: AbbVie Inc., et al.; Withdrawal of Approval of 30 New Drug Applications
Posted Date: 2022-08-16T04:00Z

[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applications be withdrawn.

DATES: Approval is withdrawn as of September 15, 2022.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]]

------------------------------------------------------------------------
      Application No.                 Drug                 Applicant
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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