Document ID: FDA-2021-N-0390-0001
Agency: fda
Document Type: Notice
Title: Lederle Laboratories et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications
Posted Date: 2021-05-12T04:00Z

[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26058-26059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09980]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0390]

Lederle Laboratories 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of June 11, 2021.

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 060164................  Nystatin Ointment....  Lederle
                                                     Laboratories,
                                                     Division of
                                                     American Cyanamid
                                                     Co., P.O. Box 8299,
                                                     Pearl River, NY
                                                     10965.
ANDA 060521................  Humatin (paromomycin   King
                              sulfate) Capsules,     Pharmaceuticals,
                              Equivalent to (EQ)     501 5th St.,
                              250 milligrams (mg)/   Bristol, TN 37620.
                              base.
ANDA 061034................  Lincomycin             The Upjohn Co.
                              Hydrochloride (HCl).   (formerly Pharmacia
                                                     and Upjohn Co.),
                                                     7000 Portage Rd.,
                                                     Kalamazoo, MI
                                                     49001.
ANDA 061652................  Oxytetracycline......  Parke Davis, 201
                                                     Tabor Rd., Morris
                                                     Plains, NJ 07950.
ANDA 061701................  Tetracycline.........  Wyeth
                                                     Pharmaceuticals,
                                                     1211 Sherwood Ave.,
                                                     Richmond, VA 23220.
ANDA 062032................  Erypar (erythromycin   Parke Davis.
                              stearate) Tablets,
                              EQ 250 mg/base and
                              EQ 500 mg/base.
ANDA 076490................  Lithium Carbonate      Hikma
                              Extended-Release       Pharmaceuticals USA
                              Tablets, 450 mg.       Inc., 1809 Wilson
                                                     Rd., Columbus, OH
                                                     43228.
ANDA 083001................  Triamcinolone          Lederle
                              Acetonide Foam.        Laboratories.
ANDA 084803................  Chlorpromazine HCl      Do.
                              Tablets, 10 mg.
ANDA 087635................  Butalbital; Aspirin;    Do.
                              Phenacetin;
                              Caffeine, Tablets.
ANDA 090102................  Ranitidine HCl Syrup,  Torrent Pharma Inc.,
                              EQ 15 mg base/         150 Allen Rd.,
                              milliliters.           Suite 102, Basking
                                                     Ridge, NJ 07920.
ANDA 206736................  Rifampin for           Watson
                              Injection, 600 mg/     Pharmaceuticals,
                              vial.                  Inc. (an indirect,
                                                     wholly owned
                                                     subsidiary of Teva
                                                     Pharmaceuticals
                                                     USA, Inc.), 400
                                                     Interpace Pkwy.,
                                                     Building A,
                                                     Parsippany, NJ
                                                     07054.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of June 
11, 2021. 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 June 11, 2021 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.

[[Page 26059]]

    Dated: May 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09980 Filed 5-11-21; 8:45 am]
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