[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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of August 20, 2020.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, [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 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).
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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