Document ID: FDA-2020-N-1227-0001
Agency: fda
Document Type: Notice
Title: Roerig Division of Pfizer Inc., et.al.; Withdrawal of Approval of 10  Abbreviated New Drug Applications
Posted Date: 2020-07-21T04:00Z

[Federal Register Volume 85, Number 140 (Tuesday, July 21, 2020)]
[Notices]
[Page 44096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15727]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1227]

Roerig Division of Pfizer Inc., et.al.; Withdrawal of Approval of 
10 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 10 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of August 20, 2020.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 060709...............  Oleandomycin           Roerig Division of
                             Injection.             Pfizer Inc., 235
                                                    East 42nd St., New
                                                    York, NY 10017.
ANDA 061087...............  Benzocaine,            Pfizer Laboratories,
                             Oxytetracycline        Division of Pfizer
                             Hydrochloride (HCl),   Inc., 235 East 42nd
                             and Polymyxin B        St., New York, NY
                             Sulfate Otic           10017.
                             Solution.
ANDA 061725...............  Tetracycline HCl       Warner Chilcott
                             Capsules, 250          Division of Warner
                             milligrams (mg) and    Lambert-Pfizer,
                             500 mg.                Inc., 235 East 42nd
                                                    St., New York, NY
                                                    10017.
ANDA 061943...............  Chloramphenicol        Lederle Laboratories,
                             Ophthalmic Solution,   Division of American
                             0.5%.                  Cyanamid Co., 1
                                                    Cyanamid Plaza,
                                                    Wayne, NJ 07470.
ANDA 062175...............  Tetracycline HCl       Warner Chilcott
                             Capsules, 250 mg.      Division of Warner
                                                    Lambert-Pfizer, Inc.
ANDA 062215...............  Oxytetracycline HCl    Lederle Laboratories,
                             Capsules.              Division of American
                                                    Cyanamid Co.
ANDA 076203...............  Ribavirin Capsules,    Kadmon
                             200 mg.                Pharmaceuticals,
                                                    LLC, 119
                                                    Commonwealth Dr.,
                                                    Warrendale, PA
                                                    15086.
ANDA 077456...............  Ribavirin Tablets,     Do.
                             200 mg, 400 mg, and
                             600 mg.
ANDA 084669...............  Chlorpropamide         Sandoz Inc., 2555 W.
                             Tablets, 250 mg.       Midway Blvd.,
                                                    Broomfield, CO
                                                    80038.
ANDA 201750...............  Articaine HCI and      Hansamed Ltd., 4761
                             Epinephrine            Tara Ct., West
                             Bitartrate for         Bloomfield, MI
                             Injection, 4%;         48323.
                             Equivalent to (EQ)
                             0.017 mg base/1.7
                             milliliters (mL);
                             (4%; EQ 0.01 mg base/
                             mL).
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
August 20, 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 August 20, 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: July 15, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15727 Filed 7-20-20; 8:45 am]
BILLING CODE 4164-01-P