[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applications be withdrawn.
DATES: Approval is withdrawn as of October 5, 2023.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.
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Application No. Drug Applicant
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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.
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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