Document ID: FDA-2023-N-3549-0001
Agency: fda
Document Type: Notice
Title: Merck Sharp & Dohme LLC, et al.; Withdrawal of Approval of 35 New Drug Applications
Posted Date: 2023-09-05T04:00Z

[Federal Register Volume 88, Number 170 (Tuesday, September 5, 2023)]
[Notices]
[Pages 60690-60691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19013]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3549]

Merck Sharp & Dohme LLC, et al.; Withdrawal of Approval of 35 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 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applications be withdrawn.

DATES: Approval is withdrawn as of October 5, 2023.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 001546.............  Guanidine (guanidine     Merck Sharp & Dohme
                          hydrochloride (HCl))     LLC, 126 East Lincoln
                          Tablets, 125             Ave., P.O. Box 2000,
                          milligrams (mg).         Rahway, NJ 07065.
NDA 010841.............  Peganone (ethotoin)      Recordati Rare
                          Tablets, 250 mg and      Diseases Inc., 100
                          500 mg.                  Corporate Dr.,
                                                   Lebanon, NJ 08833.
NDA 016801.............  Xylocaine Preservative   Fresenius Kabi USA,
                          Free (lidocaine HCl)     LLC, 3 Corporate Dr.,
                          Injection, 1%, 2%, 4%,   Lake Zurich, IL
                          10%, and 20%.            60047.
NDA 016822.............  FreAmine 8.5% (amino     B. Braun Medical Inc.,
                          acids) Injection, 8.5    901 Marcon Blvd.,
                          grams (g)/100            Allentown, PA 18109.
                          milliliters (mL).
                         FreAmine HBC 6.9%
                          (amino acids)
                          Injection, 6.9 g/100
                          mL.
                         FreAmine II 8.5% (amino
                          acids) Injection, 8.5
                          g/100 mL.
                         FreAmine III 10% (amino
                          acids) Injection, 10 g/
                          100 mL.
                         FreAmine III 8.5%
                          (amino acids)
                          Injection, 8.5 g/100
                          mL.
                         FreAmine III 8.5% with
                          electrolytes (amino
                          acids, magnesium
                          acetate, phosphoric
                          acid, potassium
                          acetate, potassium
                          chloride, sodium
                          acetate) Injection,
                          8.5%; 110mg/100mL;
                          230mg/100mL; 10mg/
                          100mL; 440mg/100mL;
                          690mg/100mL.
                         FreAmine III 3% with
                          electrolytes (amino
                          acids, magnesium
                          acetate, phosphoric
                          acid, potassium
                          chloride, sodium
                          acetate, sodium
                          chloride) Injection,
                          3%; 54mg/100mL; 40mg/
                          100mL; 150mg/100mL;
                          200mg/100mL; 120mg/
                          100mL.
NDA 017407.............  Catapres (clonidine      Boehringer Ingelheim
                          HCl) Tablets, 0.1 mg,    Pharmaceuticals,
                          0.2 mg, and 0.3 mg.      Inc., 900 Ridgebury
                                                   Rd., P.O. Box 368,
                                                   Ridgefield, CT 06877.
NDA 017425.............  Proglycem (diazoxide)    Teva Branded
                          Capsules, 50 mg and      Pharmaceutical
                          100 mg.                  Products R&D, Inc.,
                                                   145 Brandywine Pkwy.,
                                                   West Chester, PA
                                                   19380.
NDA 017534.............  Fiorinal (aspirin,       AbbVie Inc., 1 North
                          butalbital, caffeine)    Waukegan Rd., North
                          Capsules, 325 mg/50 mg/  Chicago, IL 60064.
                          40 mg.
                         Fiorinal (aspirin,
                          butalbital, caffeine)
                          Tablets, 325 mg/50 mg/
                          40 mg.
NDA 018582.............  Procalamine (amino       B. Braun Medical Inc.
                          acids, calcium
                          acetate, glycerin,
                          magnesium acetate,
                          phosphoric acid,
                          potassium chloride,
                          sodium acetate, sodium
                          chloride) Injection,
                          3%; 26mg/100mL; 3g/
                          100mL; 54mg/100mL;
                          41mg/100mL; 150mg/
                          100mL; 200mg/100mL;
                          120mg/100mL.
NDA 018676.............  HepatAmine 8% (amino     Do.
                          acids) Injection, 8g/
                          100mL.
NDA 018878.............  Indocin (indomethacin    Recordati Rare
                          sodium) Injection,       Diseases Inc.
                          equivalent to (EQ) 1
                          mg base/vial.

[[Page 60691]]

 
NDA 019099.............  Dopamine HCl and         B. Braun Medical Inc.
                          Dextrose 5% Injection,
                          80 mg/100 mL and 320
                          mg/100 mL.
                         Dopamine HCl and
                          Dextrose 5% in plastic
                          container Injection,
                          40 mg/100 mL and 160
                          mg/100 mL.
NDA 019111.............  Tussionex Pennkinetic    UCB Inc., 1950 Lake
                          (chlorpheniramine        Park Dr., Building
                          polistirex,              2100, Smyrna, GA
                          hydrocodone              30080.
                          polistirex) Extended-
                          Release Suspension, EQ
                          8 mg maleate/5 mL; EQ
                          10 mg bitartrate/5 mL.
NDA 019429.............  Fiorinal with Codeine    AbbVie Inc.
                          (aspirin, butalbital,
                          caffeine, codeine
                          phosphate) Capsules,
                          325 mg/50 mg/40 mg/30
                          mg.
NDA 019898.............  Pravachol (pravastatin   Bristol-Myers Squibb
                          sodium) Tablets, 10      Co., P.O. Box 4000,
                          mg, 20 mg, 40 mg, and    Princeton, NJ 08543.
                          80 mg.
NDA 020281.............  Ultram (tramadol HCl)    Janssen
                          Tablets, 50 mg and 100   Pharmaceuticals,
                          mg.                      Inc., 1125 Trenton-
                                                   Harbourton Rd.,
                                                   Titusville, NJ 08560.
NDA 020381.............  Niaspan (niacin)         AbbVie Inc.
                          Extended-Release
                          Tablets, 375 mg, 500
                          mg, 750 mg, and 1 g.
                         Niaspan Titration
                          Starter Pack (niacin)
                          Extended-Release
                          Tablets, 375 mg, 500
                          mg, and 750 mg.
NDA 020544.............  Jadelle                  Population Council,
                          (levonorgestrel)         1230 York Ave., New
                          Implants for Subdermal   York, NY 10065.
                          Use, 75 mg/implant.
NDA 020616.............  Kadian (morphine         AbbVie Inc.
                          sulfate) Extended-
                          Release Capsules, 10
                          mg, 20 mg, 30 mg, 40
                          mg, 50 mg, 60 mg, 70
                          mg, 80 mg, 100 mg, 130
                          mg, 150 mg, and 200 mg.
NDA 020636.............  Viramune (nevirapine)    Boehringer Ingelheim
                          Tablets, 200 mg.         Pharmaceuticals, Inc.
NDA 021065.............  Femhrt (ethinyl          Allergan
                          estradiol,               Pharmaceuticals
                          norethindrone acetate)   International Limited
                          Tablets, 0.0025 mg/0.5   c/o AbbVie Inc., 1
                          mg and 0.005 mg/1 mg.    North Waukegan Rd.,
                                                   North Chicago, IL
                                                   60064.
NDA 021066.............  Zaditor (ketotifen       Alcon Laboratories,
                          fumarate) Ophthalmic     Inc., 6201 South
                          Solution, EQ 0.025%      Freeway, Fort Worth,
                          base.                    TX 76134.
NDA 021123.............  Ultracet                 Janssen
                          (acetaminophen,          Pharmaceuticals, Inc.
                          tramadol HCl) Tablets,
                          325 mg/37.5 mg.
NDA 021513.............  Enablex (darifenacin     AbbVie Inc.
                          hydrobromide) Extended-
                          Release Tablets, EQ
                          7.5 mg base and EQ 15
                          mg base.
NDA 021615.............  Razadyne ER              Janssen Research and
                          (galantamine             Development, LLC,
                          hydrobromide) Extended-  1125 Trenton-
                          Release Capsules, EQ 8   Harbourton Rd.,
                          mg base, EQ 16 mg        Titusville, NJ 08560.
                          base, and EQ 24 mg
                          base.
NDA 021790.............  Dacogen (decitabine)     Otsuka Pharmaceutical
                          Injection, 50 mg/vial.   Co., Ltd., c/o Otsuka
                                                   Pharmaceutical
                                                   Development and
                                                   Commercialization,
                                                   Inc., 2440 Research
                                                   Blvd., Rockville, MD
                                                   20850.
NDA 021830.............  Asacol HD (mesalamine)   AbbVie Inc.
                          Delayed-Release
                          Tablets, 800 mg.
NDA 021844.............  Desonate (desonide)      LEO Pharma A/S, c/o
                          Gel, 0.05%.              LEO Pharma Inc., 7
                                                   Giralda Farms,
                                                   Madison, NJ 07940.
NDA 022292.............  Aptivus (tipranavir)     Boehringer Ingelheim
                          Oral Solution, 100 mg/   Pharmaceuticals, Inc.
                          mL.
NDA 022439.............  Zutripro                 Persion
                          (chlorpheniramine        Pharmaceuticals LLC,
                          maleate, hydrocodone     10 North Park Place,
                          bitartrate,              Suite 201,
                          pseudoephedrine HCl)     Morristown, NJ 07960.
                          Oral Solution, 4 mg/5
                          mL; 5 mg/5 mL; 60 mg/5
                          mL.
NDA 022442.............  Rezira (hydrocodone      Do.
                          bitartrate,
                          pseudoephedrine HCl)
                          Oral Solution, 5 mg/5
                          mL; 60 mg/5 mL.
NDA 204307.............  Vituz (chlorpheniramine  Do.
                          maleate, hydrocodone
                          bitartrate) Oral
                          Solution, 4 mg/5 mL; 5
                          mg/5 mL.
NDA 204768.............  Tivorbex (indomethacin)  Genus Lifesciences
                          Capsules, 20 mg and 40   Inc., 514 North 12th
                          mg.                      St., Allentown, PA
                                                   18102.
NDA 206619.............  Viekira Pak (dasabuvir   AbbVie Inc.
                          sodium; ombitasvir,
                          paritaprevir,
                          ritonavir) Tablets, EQ
                          250 mg base; 12.5 mg/
                          75 mg/50 mg.
NDA 208374.............  Bivalirudin in 0.9%      Baxter Healthcare
                          Sodium Chloride          Corp., 1 Baxter
                          Intravenous Solution,    Pkwy., Deerfield, IL
                          250 mg/50 mL and 500     60015.
                          mg/100 mL.
NDA 210583.............  Anjeso (meloxicam)       Baudax Bio, Inc., 490
                          Intravenous Solution,    Lapp Rd., Malvern, PA
                          30 mg/mL.                19355.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
October 5, 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 listed in the table 
without approved new drug applications violates sections 505(a) and 
301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) 
and 331(d)). Drug products that are listed in the table that are in 
inventory on October 5, 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: August 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19013 Filed 9-1-23; 8:45 am]
BILLING CODE 4164-01-P