[Federal Register Volume 91, Number 45 (Monday, March 9, 2026)]
[Notices]
[Pages 11321-11323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-04546]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-1302]
Aspen Global Inc. c/o Lachman Consultant Services, Inc., et al.;
Withdrawal of Approval of 46 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 46 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applications be withdrawn.
DATES: Approval is withdrawn as of April 8, 2026.
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].
[[Page 11322]]
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.
Table 1--NDAs for Which Approval Is Withdrawn
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Application No. Drug Applicant
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NDA 000552................ Liquaemin Sodium Aspen Global Inc. c/o
(heparin sodium) Lachman Consultant
injectable, 1,000 Services, Inc., 1600
units/milliliter Stewart Ave.,
(mL), 5,000 units/ Westbury, NY 11590.
mL, 10,000 units/mL,
20,000 units/mL, and
40,000 units/mL.
Liquaemin Sodium
Preservative Free
(heparin sodium)
injectable, 1,000
units/mL, 5,000
units/mL, and 10,000
units/mL.
Liquaemin Lock Flush
(heparin sodium)
injectable, 100
units/mL.
Heparin Sodium
(heparin sodium)
injectable, 1,000
units/mL, 5,000
units/mL, and 10,000
units/mL.
NDA 008370................ Bentyl (dicyclomine AbbVie Inc., 1 N
hydrochloride (HCl)) Waukegan Rd., North
injectable, 10 Chicago, IL 60064.
milligrams (mg)/mL.
Bentyl Preservative
Free (dicyclomine
HCl) injectable, 10
mg/mL.
NDA 008943................ Diamox Teva Branded
(acetazolamide) Pharmaceutical
tablets, 125 mg and Products R&D, Inc.,
250 mg. 145 Brandywine
Parkway, West
Chester, PA 19380.
NDA 011600................ Triamcinolone Extrovis AG c/o Masuu
Acetonide Global Solutions
(triamcinolone LLC, 2255 Glades
acetonide) ointment, Rd., Suite 324A,
0.025%, and 0.1%. Boca Raton, FL
33431.
NDA 012250................ Carbocaine Hospira, Inc., a
(mepivacaine HCl) Pfizer company, 275
injectable, 1%, North Field Dr.,
1.5%, and 2%. Lake Forest, IL
60045.
NDA 012623................ Flagyl Pfizer Inc., 66
(metronidazole) Hudson Blvd. East,
tablets, 250 mg and New York, NY 10001.
500 mg.
NDA 017498................ Micronase (glyburide) Do.
tablets, 1.25 mg,
2.5 mg, and 5 mg.
NDA 017630................ Sodium Iodide I-123 GE HealthCare, 3350
(sodium iodide I- North Ridge Ave.,
123) capsules, 100 Arlington Heights,
microcurie ([mu]Ci), IL 60004.
200 [mu]Ci, and
solution, 2
millicurie (mCi)/mL.
NDA 017741................ Florone (diflorasone Pfizer Inc.
diacetate) cream,
0.05%.
NDA 017802................ Lo/Ovral-28 (ethinyl Wyeth Pharmaceuticals
estradiol; LLC c/o Pfizer Inc.,
norgestrel) tablets, 66 Hudson Blvd.
0.03 mg; 0.3 mg. East, New York, NY
10001.
NDA 017948................ Norminest Fe Pfizer Inc.
(tablets, ethinyl
estradiol;
norethindrone, 0.035
mg; 0.5 mg, and
tablets, ferrous
fumarate, 75 mg).
NDA 018647................ Corzide King Pharmaceuticals
(bendroflumethiazide LLC, c/o Pfizer
; nadolol) tablets, Inc., 66 Hudson
5 mg; 40 mg and 5 Blvd. East, New
mg; 80 mg. York, NY 10001.
NDA 018799................ Protopam (pralidoxime Baxter Healthcare
chloride) Corp., 25212 W
injectable, 300 mg/ Illinois Route 120,
mL. Round Lake, IL
60073.
NDA 018926................ Norquest Fe (tablets, Pfizer Inc.
ethinyl estradiol;
norethindrone, 0.035
mg; 1 mg, and
tablets, ferrous
fumarate, 75 mg).
NDA 018947................ Sodium Lactate in Hospira, Inc.
Plastic Container
(sodium lactate),
injectable, 50
milliequivalents
(mEq)/mL.
NDA 019190................ Triphasil-28 (ethinyl Wyeth Pharmaceuticals
estradiol; c/o Pfizer Inc.
levonorgestrel)
tablets, 0.03 mg;
0.05 mg, tablets,
0.04 mg; 0.075 mg,
and tablets, 0.03
mg; 0.125 mg.
NDA 019192................ Triphasil-21 (ethinyl Do.
estradiol;
levonorgestrel)
tablets, 0.03 mg;
0.05 mg, tablets,
0.04 mg; 0.075 mg,
and tablets, 0.03
mg; 0.125 mg.
NDA 019885................ Accupril (quinapril Pfizer Inc.
HCl) tablets,
equivalent to (EQ) 5
mg base, EQ 10 mg
base, EQ 20 mg base,
and EQ 40 mg base.
NDA 019941................ Emla (lidocaine; Teva Branded
prilocaine) cream, Pharmaceutical
2.5%; 2.5%. Products R&D Inc.
NDA 019966................ Temovate (clobetasol Fougera
propionate) Pharmaceuticals
solution, 0.05%. Inc., c/o Sandoz (a
subsidiary of
Novartis), 100
College Rd., West,
Princeton, NJ 08540.
NDA 020051................ Glynase (glyburide) Pfizer Inc.
tablets, 1.5 mg, 3
mg, 4.5 mg, and 6 mg.
NDA 020125................ Accuretic Do.
(hydrochlorothiazide
; quinapril HCl)
tablets, 12.5 mg; EQ
10 mg base, 12.5 mg;
EQ 20 mg base, and
25 mg; EQ 20 mg base.
NDA 020430................ Orgaran (danaparaoid Aspen Global Inc. c/o
sodium) injectable, Lachman Consultant
750 units/0.6 mL. Services, Inc.
NDA 020682................ Glyset (miglitol) Pfizer Inc.
tablets, 25 mg, 50
mg, and 100 mg.
NDA 020859................ Sonata (zaleplon) Do.
capsules, 5 mg and
10 mg.
NDA 020862................ Hectorol Genzyme Corp., a
(doxercalciferol) Sanofi company, 450
capsules, 0.5 Water St.,
microgram (mcg), 1 Cambridge, MA 02141.
mcg, and 2.5 mcg.
NDA 020868................ Flagyl ER Pfizer Inc.
(metronidazole)
extended-release
tablet, 750 mg.
NDA 021350................ Triglide Jagotec AG c/o. ICON,
(fenofibrate) 731 Arbor Way, Suite
tablets, 50 mg and 100, Blue Bell, PA
160 mg. 19422.
NDA 021520................ Symbyax (fluoxetine Eli Lilly and Co.,
HCl; olanzapine) Lilly Corporate
capsules, EQ 25 mg Center,
base; EQ 3 mg base, Indianapolis, IN
EQ 25 mg base; EQ 6 46285.
mg base, EQ 25 mg
base; EQ 12 mg base,
EQ 50 mg base; EQ 6
mg base, and EQ 50
mg base; EQ 12 mg
base.
NDA 021688................ Sensipar (cinacalcet Amgen, Inc., 1 Amgen
HCl) tablets, EQ 30 Center Dr., Thousand
mg base, EQ 60 mg Oaks, CA 91320-1799.
base, and EQ 90 mg
base.
NDA 022200................ Bydureon (exenatide AstraZeneca
synthetic) extended- Pharmaceuticals LP,
release injection 1800 Concord Pike,
for suspension, 2 mg/ Wilmington, DE
vial. 19803.
Bydureon Pen
(exenatide
synthetic) extended-
release injection
for suspension, 2 mg.
NDA 050168................ Cortisporin Monarch
(bacitracin zinc; Pharmaceuticals, LLC
hydrocortisone; c/o Pfizer Inc., 66
neomycin sulfate; Hudson Blvd. East,
polymyxin B sulfate) New York, NY 10001.
ointment, 400 units/
gram (g); 1%; EQ 3.5
mg base/g; 5,000
units/g.
NDA 050218................ Cortisporin Do.
(hydrocortisone
acetate; neomycin
sulfate; polymyxin B
sulfate) cream,
0.5%; EQ 3.5 mg base/
g; 10,000 units/g.
NDA 050420................ Rifadin (rifampin) Sanofi-Aventis U.S.
capsules, 150 mg and LLC, a Sanofi
300 mg. company, 55
Corporate Dr.,
Bridgewater, NJ
08807.
NDA 050479................ Cortisporin Monarch
(hydrocortisone; Pharmaceuticals, LLC
neomycin sulfate; c/o Pfizer Inc.
polymyxin B sulfate)
otic solution/drops,
1%; EQ 3.5 mg base/
mL; 10,000 units/mL.
[[Page 11323]]
NDA 050533................ Vibra-Tabs Pfizer Inc.
(doxycycline
hyclate) tablet, EQ
100 mg base.
NDA 050661................ Idamycin (idarubicin Pfizer Inc.
HCL) powder, 5 mg/
vial, 10 mg/vial,
and 20 mg/vial.
NDA 050705................ Rifater (isoniazid; Sanofi-Aventis U.S.
pyrazinamide; LLC, a Sanofi
rifamin) tablets, 50 company, 100 Morris
mg; 300 mg; 120 mg. St., Morristown, NJ
07960.
NDA 201657................ Paricalcitol Hospira, Inc.
(paricalcitol)
solution, 0.002 mg/
mL (0.002 mg/mL),
0.005 mg/mL (0.005
mg/mL), and 0.01 mg/
2 mL (0.005 mg/mL).
NDA 204016................ Zoledronic Acid Do.
(zoledronic acid)
solution, EQ 4 mg
base/100 mL (EQ 0.04
mg base/mL).
NDA 204300................ Vazculep Exela Pharma
(phenylephrine HCL) Sciences, LLC, P.O.
solution, 10 mg/mL Box 818, 1245
(10 mg/mL), 50 mg/5 Blowing Rock Blvd.,
mL (10 mg/mL), and Lenoir, NC 28645.
100 mg/10 mL (10 mg/
mL).
NDA 207202................ Abilify MyCite Kit Otsuka Pharmaceutical
(aripiprazole) Co., Ltd., c/o
tablets, 2 mg, 5 mg, Otsuka
10 mg, 15 mg, 20 mg, Pharmaceutical
and 30 mg. Development &
Commercialization,
Inc., 2440 Research
Blvd., Rockville, MD
208500.
NDA 208614................ Doxercalciferol Hospira, Inc.
(doxercalciferol)
injectable, 4 mcg/2
mL (2 mcg/mL) and 10
mcg/5 mL (2 mcg/mL).
NDA 209210................ Bydureon BCise AstraZeneca
(exenatide Pharmaceuticals LP.
synthetic) extended-
release injection
suspension, 2 mg/
0.85 mL.
NDA 209269................ Minolira (minocycline EPI Health, LLC, 174
HCl) extended- Meeting St., Suite
release tablets, EQ 200, Charleston, SC
105 mg base and EQ 29401.
135 mg base.
NDA 209607................ Azedra (iobenguane I- Progenics
131) solution, 15 Pharmaceuticals,
mCi/mL. Inc., a Lantheus
company, 201
Burlington Rd.,
South Building,
Bedford, MA 01730.
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Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of April 8,
2026. 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 April
8, 2026 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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-04546 Filed 3-6-26; 8:45 am]
BILLING CODE 4164-01-P