[Federal Register Volume 84, Number 230 (Friday, November 29, 2019)]
[Notices]
[Pages 65821-65822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25901]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0163]
Hospira, Inc., et al.; Withdrawal of Approval of Six Abbreviated
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 six 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of December 30, 2019.
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, [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 described 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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ANDA 040806................. Mepivacaine Hospira, Inc., 275
Hydrochloride (HCl) North Field Dr.,
Injection USP, 3%, Bldg. H, Lake
30 milligrams (mg)/ Forest, IL 60045.
milliliter (mL).
[[Page 65822]]
ANDA 077523................. Fluconazole for Oral IVAX
Suspension, 50 mg/5 Pharmaceuticals,
mL and 200 mg/5 mL. Inc., Subsidiary of
Teva
Pharmaceuticals
USA, Inc., 425
Privet Rd.,
Horsham, PA 19044.
ANDA 078772................. Epinephrine and Hospira, Inc.
Lidocaine HCl, 0.01
mg/mL; 2% and 0.02
mg/mL; 2%.
ANDA 079138................. Articaine HCl and Do.
Epinephrine
Bitartrate
Injection, 4%; EQ
0.017 mg base/1.7
mL, 4%; EQ 0.01 mg
base/mL.
ANDA 204236................. Norethindrone Aurobindo Pharma
Acetate Tablets, 5 Ltd., 279 Princeton-
mg. Hightstown Rd.,
East Windsor, NJ
08520.
ANDA 204421................. Tramadol HCl Do.
Extended-Release
Tablets, 100 mg,
200 mg, and 300 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
December 30, 2019. Approval of each entire application is withdrawn,
including any strengths or products inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on December 30, 2019 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: November 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25901 Filed 11-27-19; 8:45 am]
BILLING CODE 4164-01-P