[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3467-3468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02032]
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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 12 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 12 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of March 14, 2019.
FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945,
[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 065343................. Epirubicin Hospira, Inc., 275
Hydrochloride (HCl) North Field Dr.,
Injection USP, 10 Bldg. H1, Lake
milligrams (mg)/5 Forest, IL 60045.
milliliters (mL),
50 mg/25 mL, 150 mg/
75 mL, and 200 mg/
100 mL.
ANDA 070562................. Flurazepam HCl Pharmaceutical
Capsules USP, 15 mg. Basics, Inc., 301
South Cherokee St.,
Denver, CO 80223.
ANDA 070563................. Flurazepam HCl Do.
Capsules USP, 30 mg.
ANDA 071808................. Flurazepam HCl Halsey Drug Co.,
Capsules USP, 15 mg. Inc., 1827 Pacific
St., Brooklyn, NY
11233.
ANDA 071809................. Flurazepam HCl Do.
Capsules USP, 30 mg.
ANDA 076827................. Vinorelbine Hospira, Inc.
Injection USP,
Equivalent to 10 mg
base/mL.
ANDA 077736................. Polyethylene Glycol Breckenridge
3350 Powder for Pharmaceutical,
Oral Solution, 17 Inc., 6111 Broken
grams/scoopful. Sound Parkway NW,
Suite 170, Boca
Raton, FL 33487.
ANDA 085763................. Glutethimide Chelsea
Tablets, 500 mg. Laboratories, Inc.,
896 Orlando Ave.,
West Hampstead, NY
11552.
ANDA 085791................. Pentobarbital Sodium Do.
Capsules, 100 mg.
ANDA 087297................. Glutethimide Phoenix
Tablets, 500 mg. Pharmaceuticals,
Inc., 111 Leuning
St., South
Hackensack, NJ
07606.
ANDA 088819................. Aristocort A Astellas Pharma
(triamcinolone U.S., Inc., Three
acetonide) Cream, Parkway North,
0.1%. Deerfield, IL
60015.
ANDA 089459................. Glutethimide Halsey Drug Co.,
Tablets, 500 mg. Inc.
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[[Page 3468]]
Therefore, approval of the applications listed in the table and all
amendments and supplements thereto, are hereby withdrawn as of March
14, 2019. 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 March 14, 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: February 7, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02032 Filed 2-11-19; 8:45 am]
BILLING CODE 4164-01-P