[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applications be withdrawn.
DATES: Approval is withdrawn as of November 9, 2020.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, [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.
[[Page 64151]]
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Application No. Drug Applicant
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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.
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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