[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Page 27128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12287]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-1740]
Novartis Pharmaceuticals Corp., et al.; Withdrawal of Approval of
Six 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 six 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of July 11, 2019.
FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945,
[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 070185............... Fluor-Op Novartis
(fluorometholone) Pharmaceuticals
Ophthalmic Corp., One Health
Suspension, 0.1%. Plaza, East Hanover,
NJ 07936.
ANDA 070858............... Trazodone Watson Laboratories,
Hydrochloride Inc., Subsidiary of
Tablets USP, 100 Teva Pharmaceuticals
milligrams (mg). USA, Inc., 425
Privet Rd., Horsham,
PA 19044.
ANDA 076023............... Hydrocodone Teva Pharmaceuticals
Bitartrate and USA, Inc., 400
Ibuprofen Tablets, Interpace Pkwy.,
7.5 mg/200 mg. Bldg. A, Parsippany,
NJ 07054.
ANDA 078167............... Paclitaxel Injection Sandoz, Inc., 100
USP, 6 mg/milliliter. College Rd. West,
Princeton, NJ 08540.
ANDA 088726............... Chlorpropamide Aurolife Pharma, LLC,
Tablets USP, 250 mg. 279 Princeton
Hightstown Rd., East
Windsor, NJ 08520.
ANDA 089852............... Chlorzoxazone Tablets Do.
USP, 250 mg.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of July
11, 2019. Approval of each entire application is withdrawn, including
any strengths or products 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 July 11, 2019 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: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12287 Filed 6-10-19; 8:45 am]
BILLING CODE 4164-01-P