Document ID: FDA-2022-N-0079-0001
Agency: fda
Document Type: Notice
Title: Hikma Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 29 New Drug Applications
Posted Date: 2022-02-02T05:00Z

[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applications be withdrawn.

DATES: Approval is withdrawn as of March 4, 2022.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.

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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