[Federal Register Volume 90, Number 67 (Wednesday, April 9, 2025)]
[Notices]
[Page 15247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-06045]
[[Page 15247]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0473]
GE HealthCare, et al.; Withdrawal of Approval of 18 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 18 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applications be withdrawn.
DATES: Approval is withdrawn as of May 9, 2025.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.
Table 1--NDAs for Which Approval Is Withdrawn
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Application No. Drug Applicant
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NDA 011386............. Hypaque (diatrizoate GE HealthCare, 251
sodium) for solution, Locke Dr.,
100%. Hypaque Marlborough, MA
(diatrizoate sodium) 01752.
solution, 40%.
NDA 017944............. MPI DMSA Kidney Reagent Do.
(technetium Tc 99m
succimer kit),
injectable.
NDA 018045............. Emcyt (estramustine Pfizer Inc., 66 Hudson
phosphate sodium) Blvd. East, New York,
capsule, equivalent to NY 10001.
(EQ) 140 milligrams
(mg) phosphate.
NDA 018141............. Technetium Tc 99m MPI GE HealthCare.
MDP (technetium Tc-99m
medronate kit),
injectable.
NDA 019697............. Ortho Tri-Cyclen Janssen
(ethinyl estradiol and Pharmaceuticals,
norgestimate, 0.035 mg/ Inc., 1125 Trenton-
0.180 mg; ethinyl Harbourton Rd.,
estradiol and Titusville, NJ 08560.
norgestimate, 0.035 mg/
0.215 mg; ethinyl
estradiol and
norgestimate, 0.035 mg/
0.250 mg) tablets.
NDA 019862............. Indiclor (indium In-111 GE HealthCare.
chloride) injectable,
2 millicurie/0.2
milliliters (mL).
NDA 019937............. Adenocard (adenosine) Astellas Pharma US,
injectable, 3 mg/mL. Inc., 1 Astellas Way,
Northbrook, IL 60062.
NDA 020357............. Glucophage (metformin EMD Serono, Inc., 200
hydrochloride (HCl)) Pier 4 Blvd., Suite
tablets, 500 mg, 625 300, Boston, MA
mg, 750 mg, 850 mg, 02210.
and 1 g.
NDA 020489............. Androderm AbbVie Inc., 1 N
(testosterone) Waukegan Rd., North
extended-release Chicago, IL 60064.
transdermal film, 1 mg/
24 hours (h), 2.5 mg/
24 h, 4 mg/24 h, and 5
mg/24 h.
NDA 020613............. Alphagan (brimonidine Allergan, Inc., 2525
tartrate) solution/ Dupont Dr., Irvine,
drops, 0.2%. CA 92612.
NDA 021145............. Vaniqa (eflornithine AbbVie Inc.
HCl) cream, 13.9%.
NDA 021202............. Glucophage XR EMD Serono, Inc.
(metformin HCl),
extended-release
tablets, 500 mg and
750 mg.
NDA 021565............. Elestat (epinastine Allergan, Inc.
HCl) ophthalmic
solution/drops, 0.05%.
NDA 021756............. Macugen (pegaptanib Bausch & Lomb Inc.,
sodium) intravitreal 400 Somerset
injectable, EQ 0.3 mg Corporate Blvd.,
acid/0.09 mL. Bridgewater, NJ
08807.
NDA 201152............. Viramune XR Boehringer Ingelheim
(nevirapine) extended- Pharmaceuticals,
release tablets, 100 Inc., 900 Ridgebury
mg and 400 mg. Road, P.O. Box 368,
Ridgefield, CT 06877.
NDA 203585............. Synribo (omacetaxine Teva Pharmaceuticals
mepesuccinate) powder GmbH, C/O Teva
for subcutaneous Branded
injection, 3.5 mg/vial. Pharmaceuticals
Products R&D, 145
Brandywine Parkway,
West Chester, PA
19380.
NDA 208424............. GoNitro (nitroglycerin) G. Pohl-Boskamp GmbH &
sublingual powder, 0.4 Co. KG, C/O Allegis
mg/packet. Pharmaceuticals, LLC,
276 Nissan Parkway
F100, Canton, MS
39046.
NDA 212121............. Potassium Phosphates CMP Development LLC,
(potassium phosphate, 8026 East Marlboro
dibasic and potassium Rd., Farmville, NC
phosphate, monobasic) 27828.
solution, 4.5 g/15 mL
(300 mg/mL), and 2.65
g/15 mL (175 mg/mL).
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Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of May 9,
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 May
9, 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: March 31, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-06045 Filed 4-8-25; 8:45 am]
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