[Federal Register Volume 87, Number 22 (Wednesday, February 2, 2022)]
[Notices]
[Pages 5827-5828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02059]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0079]
Hikma Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval
of 29 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 29 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applications be withdrawn.
DATES: Approval is withdrawn as of March 4, 2022.
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 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 006134.................. Dolophine (methadone Hikma
hydrochloride Pharmaceuticals
(HCl)) Tablets, 5 USA, Inc., 1809
milligrams (mg), Wilson Rd.,
and 10 mg. Columbus, OH 43228.
Dolophine (methadone
HCl) Syrup, 10 mg/
30 milliliter (mL).
NDA 006882.................. Phisohex Sanofi-aventis U.S.
(hexachlorophene) LLC, 55 Corporate
Emulsion, 3%. Dr., Bridgewater,
NJ 08807.
NDA 009818.................. Kemadrin Monarch
(procyclidine HCl) Pharmaceuticals,
Tablets, 2 mg, and LLC, c/o Pfizer,
5 mg. Inc., 235 East 42nd
St., New York, NY
10017.
NDA 012301.................. Librium Bausch Health US,
(chlordiazepoxide LLC, 400 Somerset
HCl), Injection, Corporate Blvd.,
100 mg/ampule. Bridgewater, NJ
08807.
NDA 013416.................. Norgesic Bausch Health US,
(orphenadrine LLC.
citrate, aspirin,
and caffeine)
Tablets, 25 mg/385
mg/30 mg.
Norgesic Forte
(orphenadrine
citrate, aspirin,
and caffeine)
Tablets, 50 mg/770
mg/60 mg.
NDA 014228.................. Spandin (aspirin and Abbott Healthcare
sodium salicylate) Pvt. Ltd., c/o G&L
Time-released Scientific,
Tablets, 7.5 grains/ Independence Blvd.,
2.5 grains. 4th Floor, Warren,
NJ 07059.
NDA 016194.................. Talwin (pentazocine Hospira Inc., 275
lactate) Injection, North Field Dr.,
equivalent to (EQ) Bldg. H1, Lake
30 mg base/mL. Forest, IL 60045.
NDA 016418.................. Inderal (propranolol Wyeth
HCl) Tablets, 10 Pharmaceuticals
mg, 20 mg, 40 mg, LLC, 235 E. 42nd
60 mg, 80 mg, and St., New York, NY
90 mg. 10017.
NDA 016704.................. Resectisol B. Braun Medical
(mannitol) Inc., 901 Marcon
Irrigation Blvd., Allentown,
Solution, 5 grams PA 18109.
(g)/100 mL.
NDA 016762.................. Inderal (propranolol Wyeth
HCl) Tablets, 10 Pharmaceuticals
mg, 20 mg, 40 mg, LLC.
60 mg, and 80 mg.
NDA 016954.................. Micronor Janssen
(norethindrone) Pharmaceuticals,
Tablets, 0.35 mg. Inc., 1125 Trenton-
Harbourton Rd.,
Titusville, NJ
08560.
NDA 017013.................. Sodium Chloride Abbott Healthcare
Injection, 20 g/100 Pvt. Ltd., c/o G&L
mL. Scientific.
NDA 017683.................. Inderal (propranolol Wyeth
HCL) Tablets, 10 Pharmaceuticals
mg, 20 mg, 40 mg, LLC.
60 mg, and 80 mg.
NDA 018423.................. Hibiclens M[ouml]lnlycke
(chlorhexidine Health Care, 5445
gluconate) Sponge, Triangle Pkwy.,
4%. Suite 400,
Peachtree Corners,
GA 30092.
NDA 018703.................. Zantac (ranitidine GlaxoSmithKline
HCl) Tablets, EQ Intellectual
150 mg base, and EQ Property Ltd.
300 mg base. England, c/o
GlaxoSmithKline, 5
Crescent Dr.,
Philadelphia, PA
19112.
NDA 019387.................. Profenal (suprofen) Alcon Laboratories,
Ophthalmic Inc., 6201 South
Solution, 1%. Freeway, Fort
Worth, TX 76134-
2099.
NDA 019530.................. Ucephan (sodium B. Braun Medical
benzoate and sodium Inc.
phenylacetate)
Solution, 100 mg/
mL; 100 mg/mL.
NDA 019675.................. Zantac (ranitidine GlaxoSmithKline
HCl) Syrup, EQ 15 Intellectual
mg base/mL. Property Ltd.
England, c/o
GlaxoSmithKline.
NDA 019814.................. Betagan (levobunolol Allergan, Inc.
HCl) Ophthalmic
Solution, 0.25%.
NDA 019927.................. Nizoral Janssen
(ketoconazole) Pharmaceuticals,
Shampoo, 2%. Inc.
[[Page 5828]]
NDA 020037.................. Voltaren (diclofenac Novartis
sodium) Ophthalmic Pharmaceuticals
Solution, 0.1%. Corp., 1 Health
Plaza, East
Hanover, NJ 07936-
1080.
NDA 021169.................. Razadyne Janssen Research &
(galantamine Development, LLC,
hydrobromide) 1125 Trenton-
Tablets, EQ 4 mg Harbourton Rd.,
base, EQ 8 mg base, Titusville, NJ
and EQ 12 mg base. 08560.
NDA 021204.................. Starlix Novartis
(nateglinide) Pharmaceuticals
Tablets, 60 mg, and Corp.
120 mg.
NDA 021406.................. Fortical (calcitonin- Upsher-Smith
salmon recombinant) Laboratories, LLC,
Nasal Spray, 200 6701 Evenstad Dr.,
International Units/ Maple Grove, MN
Spray. 55369.
NDA 021860.................. Sarafem (fluoxetine Allergan
HCl) Tablets, EQ 10 Pharmaceuticals
mg base, EQ 15 mg International Ltd.,
base, and EQ 20 mg c/o Allergan Sales,
base. LLC, 5 Giralda
Farms, Madison, NJ
07940.
NDA 202833.................. Picato (ingenol LEO Laboratories
mebutate) Gel, Ltd., c/o LEO
0.015%, and 0.05%. Pharma Inc., 7
Giralda Farms,
Madison, NJ 07940.
NDA 202880.................. Zohydro ER Recro Gainesville
(hydrocodone LLC, 1300 Gould
bitartrate) Dr., Gainesville,
Extended-release GA 30504.
Capsules, 10 mg, 15
mg, 20 mg, 30 mg,
40 mg, and 50 mg.
NDA 204683.................. Khedezla Osmotica
(desvenlafaxine) Pharmaceutical US
Extended-Release LLC, 400 Crossing
Tablets, 50 mg, and Blvd., Bridgewater,
100 mg. NJ 08807.
NDA 207916.................. Cetylev Arbor
(acetylcysteine) Pharmaceuticals,
Effervescent LLC, 6 Concourse
Tablets, 500 mg, Pkwy., Suite 1800,
and 2.5 g. Atlanta, GA 30328.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of March
4, 2022. 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 March 4, 2022 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: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02059 Filed 2-1-22; 8:45 am]
BILLING CODE 4164-01-P