Notice2023-27853
Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications
Primary source
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Published
December 19, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is withdrawing approval of eight abbreviated new drug applications (ANDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Full Text
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<title>Federal Register, Volume 88 Issue 242 (Tuesday, December 19, 2023)</title>
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[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Notices]
[Page 87787]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-27853]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5431]
Hospira, Inc., et al.; Withdrawal of Approval of Eight
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
withdrawing approval of eight abbreviated new drug applications (ANDAs)
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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of January 18, 2024.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, <a href="/cdn-cgi/l/email-protection#aee3cfdcdac6cf80e0c9dbd7cbc0eec8cacf80c6c6dd80c9c1d8"><span class="__cf_email__" data-cfemail="6d200c1f19050c43230a181408032d0b090c4305051e430a021b">[email protected]</span></a>.
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 described in Sec. 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived the 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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ANDA 063081............. Tobramycin Sulfate, Hospira, Inc., 275
Injectable, North Field Dr.,
Equivalent to (EQ) Building H1-3S, Lake
1.2 milligrams (mg) Forest, IL 60045.
base/milliliters
(mL), EQ 1.6 mg base/
mL, EQ 80 mg base/100
mL.
ANDA 063112............. Tobramycin Sulfate, Do.
Injection, EQ 10 mg
base/mL.
ANDA 078907............. Fentanyl Citrate, SpecGx LLC, 385
Troche/Lozenges, EQ Marshall Ave.,
0.2 mg base, EQ 0.4 Webster Groves, MO
mg base, EQ 0.6 mg 63119.
base, EQ 0.8 mg base,
EQ 1.2 mg base, EQ
1.6 mg base.
ANDA 080629............. Promethazine Watson Laboratories,
Hydrochloride (HCl), Inc. (an indirect,
Injectable, 50 mg/mL. wholly owned
subsidiary of Teva
Pharmaceuticals USA,
Inc.), 400 Interpace
Parkway, Building A,
Parsippany, NJ 07054.
ANDA 091170............. Zoledronic Acid, Breckenridge
Injectable, EQ 4 mg Pharmaceutical, Inc.,
base/5 mL. 15 Massirio Dr.,
Suite 201, Berlin, CT
06037.
ANDA 201846............. Azelastine HCl, Apotex Corp, U.S.
Metered Spray, 0.2055 Agent for Apotex
mg/spray. Inc., 2400 North
Commerce Parkway,
Suite 400, Weston, FL
33326.
ANDA 207698............. Nevirapine Extended- Aurobindo Pharma USA,
Release Tablets, 400 Inc., U.S. Agent for
mg. Aurobindo Pharma
Limited, 279
Princeton-Hightstown
Rd., East Windsor, NJ
08520.
ANDA 208616............. Nevirapine Extended- Do.
Release Tablets, 100
mg.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
January 18, 2024. Approval of each entire application is withdrawn,
including any strengths and dosage forms inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products listed in the table without an approved new drug
application or ANDA 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 January
18, 2024 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: December 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27853 Filed 12-18-23; 8:45 am]
BILLING CODE 4164-01-P
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