[Federal Register Volume 85, Number 123 (Thursday, June 25, 2020)]
[Notices]
[Pages 38144-38145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13661]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1528]
Pfizer 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of July 27, 2020.
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 060567............ Lidocaine Hydrochloride Pfizer Inc., 235 East
(HCl); Oxytetracycline 42nd St., New York,
Injection, 2%; 50 NY 10017.
milligrams (mg)/
milliters (mL), and
2%; 125 mg/mL.
ANDA 062612............ Gentamicin Sulfate Hospira, Inc., 275
Injection, Equivalent North Field Dr.,
to (EQ) 10 mg base/mL. Bldg. H1, Lake
Forest, IL 60045.
ANDA 062811............ Clindamycin Phosphate G&W Laboratories Inc.,
Solution, EQ 1% base. 301 Helen St., South
Plainfield, NJ 07080.
ANDA 063333............ Cefoperazone Sodium for Pfizer Inc.
Injection, EQ 1 gram
(gm) base/vial.
[[Page 38145]]
ANDA 078288............ Ondansetron HCl Baxter Healthcare
Injection, EQ 2 mg Corp., 1 Baxter
base/mL. Parkway, Deerfield,
IL 60015.
ANDA 080426............ Hydrocortisone Lotion, Bausch Health Americas
0.5%. Inc., 400 Somerset
Corporate Blvd.,
Bridgewater, NJ
08807.
ANDA 090813............ Levetiracetam Fresenius Kabi USA,
Injection, 500 mg/5 mL LLC., Three Corporate
(100 mg/mL). Dr., Lake Zurich, IL
60047.
ANDA 201751............ Articaine HCl; Hansamed Ltd., 4761
Epinephrine Bitartrate Tara Ct., West
Injection, 4%; EQ Bloomfield, MI 48323.
0.0085 mg base/1.7 mL;
4%; EQ 0.005 mg base/
mL.
ANDA 202684............ Levonorgestrel Tablets, Alvogen PB Research
0.75 mg. and Development LLC,
U.S. Agent for Lotus
Pharmaceutical Co.,
Ltd. Nantou Plant, 44
Whippany Rd., Suite
300, Morristown, NJ
07960.
ANDA 204796............ Capreomycin Sulfate for Hisun Pharmaceuticals
Injection, EQ 1 gm USA, Inc., U.S. Agent
base/vial. for Hisun
Pharmaceutical
(Hangzhou) Co., Ltd.,
200 Crossing Blvd.,
2nd Floor,
Bridgewater, NJ
08807.
ANDA 205943............ Ethinyl Estradiol; Lupin Pharmaceuticals,
Levonorgestrel Inc., 111 South
Tablets, 0.02 mg, 0.15 Calvert St.,
mg; 0.025 mg, 0.15 mg; Baltimore, MD 21202.
0.03 mg, 0.15 mg; 0.01
mg, N/A.
ANDA 212191............ Fluoxetine HCl Tablets, G&W Laboratories, Inc.
EQ 60 mg base.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of July
27, 2020. 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 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 July 27, 2020, 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: June 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13661 Filed 6-24-20; 8:45 am]
BILLING CODE 4164-01-P