Document ID: FDA-2020-N-2272-0001
Agency: fda
Document Type: Notice
Title: Hospira, Inc., et al.; Withdrawal of Approval of 27 New Drug Applications
Posted Date: 2020-12-23T05:00Z

[Federal Register Volume 85, Number 247 (Wednesday, December 23, 2020)]
[Notices]
[Pages 83973-83975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28346]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2272]

Hospira, Inc., et al.; Withdrawal of Approval of 27 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 27 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applications be withdrawn.

DATES: Approval is withdrawn as of January 22, 2021.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.

----------------------------------------------------------------------------------------------------------------
          Application No.                                  Drug                                Applicant
----------------------------------------------------------------------------------------------------------------
NDA 008809.........................  M.V.I.-12 Adult (ascorbic acid, biotin,
                                      cyanocobalamin, dexpanthenol, ergocalciferol,
                                      folic acid, niacinamide, pyridoxine
                                      hydrochloride (HCl), riboflavin 5'-phosphate
                                      sodium, thiamine HCl, vitamin A, and vitamin
                                      E) Injection, 10 milligrams (mg)/milliliters
                                      (mL), 0.006 mg/mL, 0.5 micrograms (mcg)/mL,
                                      1.5 mg/mL, 20 International Units (IU)/mL,
                                      0.04 mg/mL, 4 mg/mL, 0.4 mg/mL, 0.36 mg/mL,
                                      0.3 mg/mL, 330 Units/mL, and 1 IU/mL; and 20
                                      mg/mL, 0.006 mg/mL, 0.05 mcg/mL, 1.5 mg/mL,
                                      0.0005 mg/mL, 0.06 mg/mL, 4 mg/mL, 0.6 mg/mL,
                                      0.36 mg/mL, 0.6 mg/mL, 0.1 mg/mL, and 1 mg/mL.
                                     M.V.I.-12 Adult (ascorbic acid, biotin,          Hospira, Inc., 275 North
                                      cyanocobalamin, dexpanthenol, ergocalciferol,    Field Dr., Lake Forest,
                                      folic acid, niacinamide, pyridoxine HCl,         IL 60045.
                                      riboflavin, thiamine HCl, vitamin A, and
                                      vitamin E) Injection, 20 mg/mL, 0.006 mg/mL,
                                      0.5 mcg/mL, 1.5 mg/mL, 20 IU/mL, 0.6 mg/mL, 4
                                      mg/mL, 0.4 mg/mL, 0.36 mg/mL, 0.6 mg/mL, 330
                                      Units/mL, and 1 IU/mL..
NDA 017673.........................  Aminosyn (amino acids) Injection, 5% (5 grams
                                      (g)/100 mL), 7% (7 g/100 mL), 7% (pH6) (7 g/
                                      100 mL), 8.5% (8.5 g/100 mL), 8.5% (pH6) (8.5
                                      g/100 mL), 10% (10 g/100 mL), and 10% (pH6)
                                      (10 g/100 mL).
                                     Aminosyn 8.5% With Electrolytes (amino acids,
                                      magnesium chloride, potassium chloride, sodium
                                      chloride, and sodium phosphate dibasic)
                                      Injection, 8.5% (8.5 g/100mL), 102 mg/100 mL,
                                      487 mg/100 mL, 28 mg/100 mL, and 425 mg/100
                                      mL..
                                     Aminosyn 8.5% With Electrolytes (amino acids,    ICU Medical, Inc., 600
                                      magnesium chloride, potassium phosphate          North Field Dr., Lake
                                      dibasic, and sodium chloride) Injection, 8.5%    Forest, IL 60045.
                                      (8.5 g/100 mL), 102 mg/100 mL, 522 mg/100 mL,
                                      and 410 mg/100 mL..
NDA 017735.........................  Modicon 28 (ethinyl estradiol and                Janssen Pharmaceuticals,
                                      norethindrone) Tablets, 0.035 mg/0.5 mg.         Inc., 1125 Trenton-
                                                                                       Harbourton Rd.,
                                                                                       Titusville, NJ 08560.
NDA 017743.........................  Brevicon 28-Day (ethinyl estradiol and           Allergan Sales, LLC, 5
                                      norethindrone) Tablets, 0.035 mg/0.5 mg.         Giralda Farms, Madison,
                                                                                       NJ 07940.
NDA 017789.........................  Aminosyn 3.5% (amino acids) Injection, 3.5%
                                      (3.5 g/100 mL).
                                     Aminosyn 3.5% M (amino acids, magnesium
                                      acetate, phosphoric acid, potassium acetate,
                                      and sodium chloride) Injection, 3.5% (3.5 g/
                                      100 mL), 21 mg/100 mL, 40 mg/100 mL, 128 mg/
                                      100 mL, and 234 mg/100 mL..
                                     Aminosyn 3.5% M (amino acids, magnesium
                                      acetate, potassium acetate, and sodium
                                      chloride) Injection, 3.5% (3.5 g/100 mL), 21
                                      mg/100 mL, 128 mg/100 mL, and 234 mg/100 mL..

[[Page 83974]]

 
                                     Aminosyn 7% With Electrolytes (amino acids,      ICU Medical, Inc.
                                      magnesium chloride, potassium phosphate
                                      dibasic, and sodium chloride) Injection, 7% (7
                                      g/100 mL), 102 mg/100 mL, 410 mg/100 mL, and
                                      522 mg/100 mL..
NDA 018069.........................  Vansil (oxamniquine) Capsules, 250 mg..........  Pfizer, Inc., 235 East
                                                                                       42nd St., New York, NY
                                                                                       10017.
NDA 018081.........................  Depakene (valproic acid) Capsules, 250 mg......  AbbVie, Inc., 1 North
                                                                                       Waukegan Rd., North
                                                                                       Chicago, IL 60064.
NDA 018281.........................  Tegretol (carbamazepine) Chewable Tablets, 100   Novartis Pharmaceuticals
                                      mg.                                              Corp., 1 Health Plaza,
                                                                                       East Hanover, NJ 07936.
NDA 018429.........................  Aminosyn-RF 5.2% (amino acids) Injection, 5.2%   ICU Medical, Inc.
                                      (5.2 g/100 mL)..
NDA 018704.........................  Lopressor (metoprolol tartrate) Injection, 1 mg/ Novartis Pharmaceuticals
                                      mL.                                              Corp.
NDA 018876.........................  Potassium Chloride 5 milliequivalent (mEq) in
                                      Dextrose 5% and Sodium Chloride 0.3% in
                                      Plastic Container (dextrose, potassium
                                      chloride, and sodium chloride) Injection, 5 g/
                                      100 mL, 74.5 mg/100 mL, and 300 mg/100 mL.
                                     Potassium Chloride 5 mEq in Dextrose 5% and
                                      Sodium Chloride 0.3% in Plastic Container
                                      (dextrose, potassium chloride, and sodium
                                      chloride) Injection, 5 g/100 mL, 149 mg/100
                                      mL, and 300 mg/100 mL..
                                     Potassium Chloride 10 mEq in Dextrose 5% and
                                      Sodium Chloride 0.3% in Plastic Container
                                      (dextrose, potassium chloride, and sodium
                                      chloride) Injection, 5 g/100 mL, 74.5 mg/100
                                      mL, and 300 mg/mL..
                                     Potassium Chloride 10 mEq in Dextrose 5% and
                                      Sodium Chloride 0.3% in Plastic Container
                                      (dextrose, potassium chloride, and sodium
                                      chloride) Injection, 5 g/100 mL, 149 mg/100
                                      mL, and 300 mg/mL..
                                     Potassium Chloride 15 mEq in Dextrose 5% and
                                      Sodium Chloride 0.3% in Plastic Container
                                      (dextrose, potassium chloride, and sodium
                                      chloride) Injection, 5 g/100 mL, 224 mg/100
                                      mL, and 300 mg/100 mL..
                                     Potassium Chloride 20 mEq in Dextrose 5% and
                                      Sodium Chloride 0.3% in Plastic Container
                                      (dextrose, potassium chloride, and sodium
                                      chloride) Injection, 5 g/100 mL, 298 mg/100
                                      mL, and 300 mg/100 mL..
                                     Potassium Chloride 20 mEq in Dextrose 5% in
                                      Sodium Chloride 0.3% in Plastic Container
                                      (dextrose, potassium chloride, and sodium
                                      chloride) Injection, 5 g/100 mL, 149 mg/100
                                      mL, and 300 mg/100 mL..
                                     Potassium Chloride 30 mEq in Dextrose 5% and
                                      Sodium Chloride 0.3% in Plastic Container
                                      (dextrose, potassium chloride, and sodium
                                      chloride) Injection, 5 g/100 mL, 224 mg/100
                                      mL, and 300 mg/100 mL..
                                     Potassium Chloride 40 mEq in Dextrose 5% and     Do.
                                      Sodium Chloride 0.3% in Plastic Container
                                      (dextrose, potassium chloride, and sodium
                                      chloride) Injection, 5 g/100 mL, 298 mg/100
                                      mL, and 300 mg/100 mL..
NDA 018985.........................  Ortho Novum 7/7/7 (ethinyl estradiol and         Janssen Pharmaceuticals,
                                      norethindrone) (White) Tablets, 0.035 mg         Inc.
                                      ethinyl estradiol and 0.5 mg norethindrone,
                                      (Light Peach) Tablets, 0.035 mg ethinyl
                                      estradiol and 0.75 mg norethindrone, (Peach)
                                      Tablets, 0.035 mg ethinyl estradiol and 1 mg
                                      norethindrone.
NDA 019029.........................  Metronidazole Tablets, 250 mg..................  LNK International, Inc.,
                                                                                       145 Ricefield Lane,
                                                                                       Hauppauge, NY 11788.
NDA 019374.........................  Aminosyn-HBC 7% (amino acids) Injection, 7% (7   ICU Medical, Inc.
                                      g/100 mL)..
NDA 019435.........................  Nix (permethrin) Topical Lotion, 1%............  GlaxoSmithKline Consumer
                                                                                       Healthcare Holdings (US)
                                                                                       LLC, 184 Liberty Corner
                                                                                       Rd., suite 2000, Warren,
                                                                                       NJ 07059.
NDA 019437.........................  Aminosyn II M (amino acids, magnesium chloride,
                                      potassium chloride, sodium chloride, and
                                      sodium phosphate dibasic heptahydrate)
                                      Injection, 3.5% (3.5 g/100 mL), 30 mg/100 mL,
                                      97 mg/100 mL, 120 mg/100 mL, and 49 mg/100 mL.
                                     Aminosyn II With Electrolytes (amino acids,
                                      magnesium chloride, potassium chloride,
                                      potassium phosphate dibasic, and sodium
                                      chloride) Injection, 7% (7 g/100 mL), 102 mg/
                                      100 mL, 45 mg/100 mL, 522 mg/100 mL, and 410
                                      mg/100 mL; 8.5% (8.5 g/100 mL), 102 mg/100 mL,
                                      45 mg/100 mL, 522 mg/100 mL, and 410 mg/100
                                      mL; and 10% (10 g/100 mL), 102 mg/100 mL, 45
                                      mg/100 mL, 522 mg/100 mL, and 410 mg/100 mL..
                                     Aminosyn II With Electrolytes (amino acids,      Do.
                                      magnesium chloride, potassium chloride, sodium
                                      chloride, and sodium phosphate dibasic)
                                      Injection, 8.5% (8.5 g/100 mL), 102 mg/100 mL,
                                      492 mg/100 mL, 60 mg/100 mL, and 425 mg/100
                                      mL..
NDA 019438.........................  Aminosyn II 3.5% (amino acids) Injection, 3.5%
                                      (3.5 g/100 mL).
                                     Aminosyn II 5% (amino acids) Injection, 5% (5 g/
                                      100 mL).
                                     Aminosyn II 7% (amino acids) Injection, 7% (7 g/
                                      100 mL)..
                                     Aminosyn II 8.5% (amino acids) Injection, 8.5%
                                      (8.5 g/100 mL)..
                                     Aminosyn II 10% (amino acids) Injection, 10%     Do.
                                      (10 g/100 mL)..
NDA 019653.........................  Ortho-Cyclen-21 (ethinyl estradiol and
                                      norgestimate) Oral-21 Tablets, 0.035 mg/0.250
                                      mg.
                                     Ortho Cyclen-28 (ethinyl estradiol and           Janssen Pharmaceuticals,
                                      norgestimate) Oral-28 Tablets, 0.035 mg/0.25     Inc.
                                      mg..
NDA 019894.........................  Dextrose 50% in Plastic Container (dextrose)     ICU Medical, Inc.
                                      Injection, 50 g/100 mL.

[[Page 83975]]

 
NDA 019916.........................  Morphine Sulfate Injection, 1 mg/mL and 5 mg/mL  Do.
NDA 020593.........................  Depacon (valproate sodium) Injection,            AbbVie, Inc.
                                      Equivalent to (EQ) 100 mg base/mL.
NDA 020634.........................  Levaquin (levofloxacin) Tablets, 250 mg, 500     Janssen Pharmaceuticals,
                                      mg, and 750 mg.                                  Inc.
NDA 021241.........................  Ortho Tri-Cyclen Lo (ethinyl estradiol and       Do.
                                      norgestimate) Oral-28 (White) Tablets, 0.025
                                      mg ethinyl estradiol and 0.18 mg norgestimate;
                                      (Light Blue) Tablets, 0.025 mg ethinyl
                                      estradiol and 0.215 mg norgestimate; (Dark
                                      Blue) Tablets, 0.025 mg ethinyl estradiol and
                                      0.250 mg norgestimate.
NDA 206544.........................  MorphaBond ER (morphine sulfate) Extended-       Daiichi Sankyo, Inc., 211
                                      Release Tablets, 15 mg, 30 mg, 60 mg, and 100    Mount Airy Rd., Basking
                                      mg.                                              Ridge, NJ 07920.
NDA 208399.........................  Varubi (rolapitant HCl) Injectable Emulsion, EQ  TerSera Therapeutics LLC,
                                      166.5 mg base/92.5 mL (EQ 1.8 mg base/mL).       520 Lake Cook Rd., suite
                                                                                       500, Deerfield, IL 60015.
NDA 209203.........................  Duzallo (allopurinol and lesinurad) Tablets,     Ironwood Pharmaceuticals,
                                      200 mg/200 mg and 300 mg/200 mg.                 Inc., 100 Summer St.,
                                                                                       suite 2300, Boston, MA
                                                                                       02110.
NDA 210895.........................  Welchol (colesevelam HCl) Chewable Bars, 3.75 g  Daiichi Sankyo, Inc.
----------------------------------------------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
January 22, 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 January 22, 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: December 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28346 Filed 12-22-20; 8:45 am]
BILLING CODE 4164-01-P