[Federal Register Volume 90, Number 147 (Monday, August 4, 2025)]
[Notices]
[Pages 36440-36441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-14683]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2422]
Teva Branded Pharmaceutical Products R&D, Inc., et al.;
Withdrawal of Approval of 39 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 39 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applications be withdrawn.
DATES: Approval is withdrawn as of September 3, 2025.
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 table 1 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.
Table1--NDAs for Which Approval Is Withdrawn
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Application No. Drug Applicant
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NDA 012674................ Hexadrol Aspen Global Inc.,
(dexamethasone), c/o Lachman
Elixir, 0.5 mg/5 Consultant
milliliter (mL). Services, Inc.,
1600 Stewart
Ave., Westbury,
NY 11590.
NDA 012675................ Hexadrol (dexamethasone) Do.
Tablets, 0.5 mg, 0.75
mg, 1.5 mg, and 4 mg.
NDA 014694................ Hexadrol (dexamethasone Do.
sodium phosphate)
Injectable, Equivalent
to (EQ) 4 mg phosphate/
mL, EQ 10 mg phosphate/
mL, and EQ 20 mg
phosphate/mL.
NDA 016012................ Vivactil (protriptyline Teva Women's
hydrochloride (HCl)) Health, Inc, 145
Tablets, 5 mg and 10 mg. Brandywine
Parkway, West
Chester, PA
19380.
NDA 016792................ Surmontil (trimipramine Do.
maleate) Capsules, EQ
25 mg base, EQ 50 mg
base, and EQ 100 mg
base.
NDA 016798................ Sinequan (doxepin HCl) Pfizer Inc, 66
Capsules, EQ 10 mg Hudson Blvd.
base, EQ 25 mg base, EQ East, New York,
50 mg base, EQ 75 mg NY 10001.
base, EQ 100 mg base,
and EQ 150 mg base.
NDA 017516................ Sinequan (doxepin HCl) Do.
Concentrate, EQ 10 mg
base/mL.
NDA 017525................ Loxitane (loxapine Teva Branded
succinate) Capsules, EQ Pharmaceutical
5 mg base, EQ 10 mg Products R&D,
base, EQ 25 mg base, LLC, 145
and EQ 50 mg base; Brandywine
Loxitane (loxapine Parkway, West
succinate) Tablets, EQ Chester, PA
10 mg base, EQ 25 mg 19380.
base, and EQ 50 mg base.
NDA 017658................ Loxitane C (loxapine Do.
HCl) Concentrate, EQ 25
mg base/mL.
NDA 017693................ Drytec Technetium Tc99m GE HealthCare, 251
Generator (technetium Locke Dr.,
Tc99m sodium Marlborough, MA
pertechnetate 01752.
generator) Solution,
830-16600 millicurie
(mCi)/generator, and 68-
2703 mCi/generator.
NDA 018110................ Thallous Chloride Tl-201 Do.
(thallous chloride Tl-
201) Injectable, 1 mCi/
mL.
NDA 018920................ M.V.I. Pediatric Hospira, Inc., a
(ascorbic acid 80mg/ Pfizer company,
vial; biotin 0.02 mg/ 275 North Field
vial; cyanocobalamin Drive, Lake
0.001mg/vial; Forest, IL 60045.
dexpanthenol 5 mg/vial;
ergocalciferol 0.01mg/
vial; folic acid 0.14
mg/vial; niacinamide 17
mg/vial; phytonadione
0.2 mg/vial; pyridoxine
HCl 1 mg/vial;
riboflavin 5'-phosphate
sodium 1.4 mg/vial;
thiamine HCl EQ 1.2 mg
base/vial; vitamin A
0.7 mg/vial; vitamin E
7 mg/vial) For Solution.
NDA 019240................ E-Z Scrub 201 (povidone- Becton, Dickinson
iodine) Sponge, 20%. and Company, 75 N
Fairway Dr.,
Vernon Hills, IL
60061.
NDA 019476................ E-Z Scrub 241 (povidone- Do.
iodine) Sponge, 10%.
NDA 020551................ Nimbex (cisatracurium AbbVie Inc., N
besylate) Injectable, Waukegan Rd.,
EQ 2 mg base/mL; Nimbex North Chicago, IL
Preservative Free 60064.
(cisatracurium
besylate) Injectable,
EQ 2 mg base/mL and EQ
10 mg base/mL.
NDA 020655................ Alora (estradiol) Do.
Extended-release Films,
0.025 mg/24 hour, 0.05
mg/24 hour, 0.075 mg/24
hour, and 0.1 mg/24
hour.
NDA 020933................ Viramune (nevirapine), Boehringer
Suspension, 50 mg/5 mL. Ingelheim
Pharmaceuticals,
Inc., 900
Ridgebury Rd.,
Ridgefield, CT
06877-0369.
NDA 021071................ Avandia (rosiglitazone Woodward Pharma
maleate) Tablets, EQ 2 Services, LLC,
mg base, EQ 4 mg base, 11705 Boyette
and EQ 8 mg base. Rd., Riverview,
FL 33569.
NDA 021290................ Zinecard (dexrazoxane Pfizer Inc.
HCl) Injectable, EQ 250
mg base/vial and EQ 500
mg base/vial.
NDA 021591................ Riomet (metformin HCl) Ranbaxy Signature
Solution, 500 mg/5 mL. LLC c/o Sun
Pharmaceutical
Industries, Inc.,
2 Independence
Way, Princeton,
NJ 08540.
[[Page 36441]]
NDA 021610................ Opana ER (oxymorphone Endo Operations
HCl) Extended-release Limited, c/o Endo
Tablets, 5 mg, 7.5 mg, USA, Inc., 9
10 mg, 15 mg, 20 mg, 30 Great Valley
mg, and 40 mg. Parkway, Malvern,
PA 19355.
NDA 021625................ M.V.I. Adult (ascorbic Hospira, Inc., a
acid 200 mg/vial; Pfizer company.
biotin 0.06 mg/vial;
cyanocobalamin 0.005 mg/
vial; dexpanthenol 15
mg/vial; ergocalciferol
0.005 mg/vial; folic
acid 0.6 mg/vial;
niacinamide 40 mg/vial;
pyridoxine HCl 6 mg/
vial; riboflavin 5'-
phosphate sodium 3.6 mg/
vial; thiamine HCl 6 mg/
vial; Vitamin A 1 mg/
vial; Vitamin E 10 mg/
vial; Vitamin K 0.15 mg/
vial) Injectable.
NDA 021773................ Byetta (exenatide AstraZeneca AB c/o
synthetic) Injectable, AstraZeneca
300 micrograms (mcg)/ Pharmaceuticals
1.2 mL and 600 mcg/2.4 LP, 1800 Concord
mL. Pike, Wilmington,
DE 19803.
NDA 022107................ Tekturna HCT (aliskiren Noden Pharma DAC c/
hemifumarate and o APCER Life
hydrochlorothiazide) Sciences, 111
Tablets, EQ 150 mg Town Square
base; 12.5 mg, EQ 150 Place, Suite 860,
mg base; 25 mg, EQ 300 Jersey City, NJ
mg base; 12.5 mg, and 7310.
EQ 300 mg base; 25 mg.
NDA 022200................ Bydureon (exenatide AstraZeneca AB c/o
synthetic) For AstraZeneca
Suspension, Extended- Pharmaceuticals
release, 2 mg/vial; LP.
Bydureon Pen (exenatide
synthetic) For
Suspension, Extended-
release, 2 mg.
NDA 022450................ Ofirmev (acetaminophen) Mallinckrodt
Solution, 1000 mg/100 Pharmaceuticals
mL (10 mg/mL). Ireland Limited,
Mallinckrodt
Hospital Products
Inc., 675 James
S. McDonnell
Blvd., Hazelwood,
MO 63042.
NDA 022519................ Duexis (famotidine and Horizon Medicines
ibuprofen) Tablet, 26.6 LLC, 1 Horizon
mg; 800 mg. Way, Deerfield,
IL 60015.
NDA 050577................ Zanosar (streptozocin) Teva
Injectable, 1 gram(g)/ Pharmaceuticals
vial. USA, Inc., 145
Brandywine
Parkway, West
Chester, PA
19380.
NDA 050693................ Zithromax Pfizer Inc.
(azithromycin), for
Suspension, EQ 1 g base/
packet.
NDA 050591................ Bactroban (mupirocin) SmithKlineBeecham
Ointment, 2%. (Cork) Ltd.,
Ireland c/o
GlaxoSmithKline,
1250 South
Collegeville Rd.,
Collegeville, PA
19426.
NDA 050703................ Bactroban (mupirocin) Do.
Nasal Ointment, 2%.
NDA 050746................ Bactroban (mupirocin) Do.
Cream, 2%.
NDA 050797................ Zmax (azithromycin) for PF Prism C.V. c/o
Suspension, Extended- Pfizer, Inc., 235
release, EQ 2 g base/ East 42nd St.,
bottle. New York, NY
10017.
NDA 207986................ Otiprio (ciprofloxacin) ALK-Abell[oacute],
Injectable and Otic Inc. c/o ALK
Suspension, 6% (60 mg/ Inc., 135 Route
mL). 202/206 Suite 3,
Bedminster, NJ
07921.
NDA 208653................ Apadaz (acetaminophen Zevra
and benzhydrocodone Therapeutics,
HCl), Tablets, 325 mg; 1180 Celebration
EQ 4.08 mg base, 325 Blvd., Suite 103,
mg; EQ 6.12 mg base, Celebration, FL
and 325 mg; EQ 8.16 mg 34747.
base.
NDA 209210................ Bydrueon BCise AstraZeneca AB c/o
(exenatide synthetic) AstraZeneca
Extended-release Pharmaceuticals
Suspension, 2 mg/0.85 LP.
mL.
NDA 209410................ Osmolex ER (amantadine Supernus
HCl) Extended-release Pharmaceuticals,
Tablets, EQ 129 mg Inc., 9715 Key
base, EQ 161 mg base, West Ave.,
EQ 193 mg base, and EQ Rockville, MD
258 mg base. 20850.
NDA 212895................ Conjupri (levamlodipine CSPC Ouyi
maleate) Tablets, EQ Pharmaceutical
1.25 mg base, EQ 2.5 mg Co., Ltd. c/o
base, and EQ 5 mg base. CSPC Conjupro
Biotherapeutics,
Inc., 302
Carnegie Center,
Suite 100,
Princeton, NJ
08540.
NDA 214835................ Risvan (risperidone) for Laboratorios
Suspension, Extended- Farmac[eacute]uti
release, 75 mg and 100 cos ROVI, S.A. c/
mg. o PharmaLex US
Corporation, 1
West 1st Ave.,
Conshohocken, PA
19428.
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Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of September
3, 2025. Approval of each entire application is withdrawn, including
any strengths and dosage forms included in the application but
inadvertently missing from table 1. Introduction or delivery for
introduction into interstate commerce of products listed in table 1
without an approved NDA 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 table 1 that are in inventory on
September 3, 2025 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: July 30, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14683 Filed 8-1-25; 8:45 am]
BILLING CODE 4164-01-P