Document ID: FDA-2020-N-1867-0001
Agency: fda
Document Type: Notice
Title: Novartis Pharmaceuticals Corp., et al.; Withdrawal of Approval of 13 New
Drug Applications
Posted Date: 2020-10-09T04:00Z

[Federal Register Volume 85, Number 197 (Friday, October 9, 2020)]
[Notices]
[Pages 64150-64151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22402]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1867]

Novartis Pharmaceuticals Corp., et al.; Withdrawal of Approval of 
13 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 13 new drug applications (NDAs) 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applications be withdrawn.

DATES: Approval is withdrawn as of November 9, 2020.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, Kimberly.Lehrfeld@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.

[[Page 64151]]

 
------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
NDA 003290..................  Neo-Calglucon         Novartis
                               (calcium              Pharmaceuticals
                               glubionate) Syrup.    Corp., 1 Health
                                                     Plaza, East
                                                     Hanover, NJ 07936.
NDA 009816..................  Cortef Acetate        Upjohn, a Pfizer
                               S.E.E. Drops          Division, 235 East
                               (hydrocortisone       42nd St., New York,
                               acetate) Ophthalmic   NY 10017.
                               Solution.
NDA 009817..................  Cortef Acetate        Do.
                               (hydrocortisone
                               acetate) Ophthalmic
                               Ointment, 1.5%.
NDA 010645..................  Optef Drops           Do.
                               (hydrocortisone
                               probutate)
                               Ophthalmic
                               Solution, 0.2%.
NDA 010155..................  Mytelase (ambenonium  Sanofi-Aventis U.S.
                               chloride) Tablets,    LLC, 55 Corporate
                               10 milligrams (mg).   Dr., Bridgewater,
                                                     NJ 08807.
NDA 016659..................  Norinyl 1 + 50        Actavis Laboratories
                               (norethindrone and    Ut, Inc. (an
                               mestranol) Tablets,   indirect, wholly
                               1 mg/0.05 mg.         owned subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA, Inc.), 41
                                                     Moores Rd., Frazer,
                                                     PA 19355.
NDA 016807..................  Thyrolar (liotrix     Allergan Sales, LLC,
                               [tetraiodothyronine   5 Giralda Farms,
                               levothyroxine         Madison, NJ 07940.
                               sodium (T4) and
                               triiodothyronine
                               liothyronine sodium
                               (T3)]) Tablets,
                               0.0125 mg/0.0031
                               mg, 0.025 mg/0.0063
                               mg, 0.05 mg/0.0125
                               mg, 0.1 mg/0.025
                               mg, 0.15 mg/0.0375
                               mg, and 0.25 mg/
                               0.0625 mg.
NDA 017919..................  Ortho Novum 1/35      Janssen
                               (ethinyl estradiol    Pharmaceuticals,
                               and norethindrone)    Inc., 1125 Trenton-
                               Tablets, 0.035 mg/1   Harbourton Rd.,
                               mg.                   Titusville, NJ
                                                     08560.
NDA 018768..................  VePesid (etoposide)   Corden Pharma Latina
                               Injection, 20 mg/mL.  S.p.A., c/o
                                                     Clinipace Inc.,
                                                     1434 Spruce St.,
                                                     Suite 100, Boulder,
                                                     CO 80302.
NDA 019972..................  Ocupress (carteolol   Novartis
                               hydrochloride)        Pharmaceuticals
                               Ophthalmic            Corp.
                               Solution, 1%.
NDA 021590..................  FazaClo (clozapine)   Jazz Pharmaceuticals
                               Orally                Ireland Ltd., c/o
                               Disintegrating        Jazz
                               Tablets, 12.5 mg,     Pharmaceuticals,
                               25 mg, 100 mg, 150    Inc., 3170 Porter
                               mg, and 200 mg.       Dr., Palo Alto, CA
                                                     94304.
NDA 021664..................  Bromday/Xibrom        Bausch & Lomb Inc.,
                               (bromfenac)           400 Somerset
                               Ophthalmic            Corporate Blvd.,
                               Solution,             Bridgewater, NJ
                               Equivalent to 0.09%.  08807.
NDA 022018..................  Lamivudine and        Pharmacare Ltd., c/o
                               Zidovudine Tablets,   Lachman Consultants
                               150 mg lamivudine     Services, Inc.,
                               and 300 mg            1600 Stewart Ave.,
                               zidovudine.           Suite 604,
                                                     Westbury, NY 11590.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
November 9, 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 November 9, 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: October 5, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22402 Filed 10-8-20; 8:45 am]
BILLING CODE 4164-01-P