Notice2021-23729
Allergan Sales, LLC, et al.; Withdrawal of Approval of 18 New Drug Applications
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 1, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 18 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Full Text
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<title>Federal Register, Volume 86 Issue 208 (Monday, November 1, 2021)</title>
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[Federal Register Volume 86, Number 208 (Monday, November 1, 2021)]
[Notices]
[Pages 60251-60252]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23729]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1071]
Allergan Sales, LLC, et al.; Withdrawal of Approval of 18 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 18 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applications be withdrawn.
DATES: Approval is withdrawn as of December 1, 2021.
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.
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 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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NDA 007409............. Bentyl (dicyclomine Allergan Sales, LLC, 5
hydrochloride (HCl)) Giralda Farms,
Capsules, 10 milligram Madison, NJ 07940.
(mg).
Bentyl (dicyclomine
HCl) Tablets, 20 mg.
NDA 013625............. Norinyl 1 + 50 Actavis Laboratories
(norethindrone and UT, Inc. (an
mestranol) Tablets, indirect, wholly
0.05 mg/1 mg. owned subsidiary of
Norinyl (norethindrone Teva Pharmaceuticals
and mestranol) USA, Inc.), 145
Tablets, 0.1 mg/2 mg. Brandywine Pkwy.,
West Chester, PA
19380.
NDA 014169............. Dendrid (idoxuridine) Alcon Laboratories,
Ophthalmic Solution, Inc., 6201 South
0.1%. Freeway, Fort Worth,
TX 76134.
NDA 019404............. Ocufen (flurbiprofen Allergan, Inc., 2525
sodium) Ophthalmic Dupont Dr., Irvine,
Solution, 0.03%. CA 92612.
NDA 019784............. Ibuprofen Oral Abbott Laboratories
Suspension, 100 mg/5 Established
milliliters (mL). Pharmaceuticals
Products Division,
200 Abbott Park Rd.,
Abbott Park, IL
60064.
NDA 020010............. Lotrisone Merck Sharp and Dohme
(betamethasone Corp., a subsidiary
dipropionate and of Merck and Co.,
clotrimazole) Lotion, Inc., 1 Merck Drive,
Equivalent to (EQ) P.O. Box 100,
0.05% base/1%. Whitehouse Station,
NJ 08889.
NDA 020098............. Mivacron (mivacurium AbbVie, Inc., 1 N
chloride) Solution, EQ Waukegan Rd., North
2 mg base/mL, EQ 10 mg Chicago, IL 60064
base/5 mL, and EQ 20
mg base/10 mL.
Mivacron in Dextrose 5%
in plastic container
(mivacurium chloride)
Injectable, EQ 0.5 mg
base/mL and EQ 50 mg
base/100 mL.
NDA 020412............. Zerit (stavudine) Bristol-Myers Squibb
Capsules, 5 mg, 15 mg, Co., P.O. Box 4000,
20 mg, 30 mg, and 40 Princeton, NJ 08543.
mg.
[[Page 60252]]
NDA 020509............. Gemzar (gemcitabine Eli Lilly and Co.,
HCl) Injection, EQ 200 Lilly Corporate
mg base and EQ 1 gram Center, Indianapolis,
(g) base. IN 46285.
NDA 020696............. Antizol (fomepizole) Par Sterile Products,
Injection, 1.5 g/1.5 LLC, 6 Ram Ridge Rd.,
mL. Chestnut Ridge, NY
10977.
NDA 020705............. Rescriptor (delavirdine ViiV Healthcare Co., 5
mesylate) Tablets, 100 Moore Dr., Research
mg and 200 mg. Triangle Park, NC
27709.
NDA 021114............. Betaxon (levobetaxolol Alcon Laboratories,
HCl) Ophthalmic Inc.
Suspension, EQ 0.5%
base.
NDA 021199............. Quixin (levofloxacin) Santen Inc., 6401
Ophthalmic Solution, Hollis St., Suite
0.5%. 125, Emeryville, CA
94608.
NDA 021571............. Iquix (levofloxacin) Do.
Ophthalmic Solution,
1.5%.
NDA 050704............. DaunoXome (daunorubicin Galen Limited, 25
citrate liposome Fretz Rd., Souderton,
injection), EQ 2 mg PA 18964.
base/mL.
NDA 204736............. AcipHex Sprinkle Aytu BioScience Inc.,
(rabeprazole sodium) 373 Inverness
Delayed Release Parkway, Suite 206,
Capsules, 5 mg and 10 Englewood, CO 80112.
mg.
NDA 205060............. Epanova (omega-3- AstraZeneca
carboxylic acids) Pharmaceuticals LP,
Capsules, 1 gram (1 g 1800 Concord Pike,
contains at least 850 Wilmington, DE 19803.
mg of polyunsaturated
fatty acids).
NDA 206843............. Daklinza (daclatasvir Bristol-Myers Squibb
dihydrochloride) Co.
Tablets, EQ 30 mg
base, EQ 60 mg base,
and EQ 90 mg base.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
December 1, 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 December 1, 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.
Dated: October 25, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23729 Filed 10-29-21; 8:45 am]
BILLING CODE 4164-01-P
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