Document ID: FDA-2020-N-1528-0001
Agency: fda
Document Type: Notice
Title: Pfizer Inc., et.al.; Withdrawal of Approval of 12 Abbreviated New Drug
Applications
Posted Date: 2020-06-25T04:00Z

[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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of July 27, 2020.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, Martha.Nguyen@fda.hhs.gov.

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.

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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