[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)]
[Notices]
[Pages 58257-58259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25187]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4142]


Determination That REGITINE (Phentolamine Mesylate) Injection, 5 
Milligrams/Vial, and Other Drug Products Were Not Withdrawn From Sale 
for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that the drug products listed in this document were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination means that FDA will not begin procedures to withdraw 
approval of abbreviated new drug applications (ANDAs) that refer to 
these drug products, and it will allow FDA to continue to approve ANDAs 
that refer to the products as long as they meet relevant legal and 
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, 
[email protected].

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
applicants must, with certain exceptions, show that the drug for which 
they are seeking approval contains the same active ingredient in the 
same strength and dosage form as the ``listed drug,'' which is a 
version of the drug that was previously approved. ANDA applicants do 
not have to repeat the extensive clinical testing otherwise necessary 
to gain approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products With Therapeutic 
Equivalence Evaluations,'' which is generally known as the ``Orange 
Book.'' Under FDA regulations, a drug is removed from the list if the 
Agency withdraws or suspends approval of the drug's NDA or ANDA for 
reasons of safety or effectiveness, or if FDA determines that the 
listed drug was withdrawn from sale for reasons of safety or 
effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must 
determine whether a listed drug was withdrawn from sale for reasons of 
safety or effectiveness: (1) Before an ANDA that refers to that listed 
drug may be approved, (2) whenever a listed drug is voluntarily 
withdrawn from sale and ANDAs that refer to the listed drug have been 
approved, and (3) when a person petitions for such a determination 
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if 
FDA determines that a listed drug was withdrawn from sale for safety or 
effectiveness reasons, the Agency will initiate proceedings that could 
result in the withdrawal of approval of the ANDAs that refer to the 
listed drug.
    FDA has become aware that the drug products listed in the table are 
no longer being marketed.

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          Application No.                   Drug name         Active ingredient(s)        Strength(s)         Dosage form/route          Applicant
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 008278.........................  REGITINE..............  Phentolamine Mesylate.  5 milligrams (mg)/     Injectable; Injection  Novartis
                                                                                      vial.                                         Pharmaceuticals
                                                                                                                                    Corp.
NDA 011287.........................  KAYEXALATE............  Sodium Polystyrene      453.6 grams (g)/       Powder; Oral, Rectal.  Concordia
                                                              Sulfonate.              bottle.                                       Pharmaceuticals,
                                                                                                                                    Inc.
NDA 011751.........................  PROLIXIN..............  Fluphenazine            2.5 mg/milliliter      Injectable;            Bristol-Myers Squibb
                                                              Hydrochloride (HCl).    (mL).                  Injection;.            Co.
                                                             Fluphenazine HCl......  1 mg; 2.5 mg; 5 mg;    Tablet; Oral.........
                                                                                      10 mg.
NDA 012249.........................  LIBRIUM...............  Chlordiazepoxide HCl..  5 mg; 10 mg; 25 mg...  Capsule; Oral........  Valeant
                                                                                                                                    Pharmaceuticals
                                                                                                                                    North America, LLC.
NDA 016008.........................  PERMITIL..............  Fluphenazine HCl......  5 mg/mL..............  Concentrate; Oral....  Schering Corp.,
                                                                                                                                    Subsidiary of
                                                                                                                                    Schering Plough,
                                                                                                                                    Corp.
NDA 016110.........................  PROLIXIN ENANTHATE....  Fluphenazine Enanthate  25 mg/mL.............  Injectable; Injection  Bristol-Myers Squibb
                                                                                                                                    Co.
NDA 017007.........................  HEPARIN SODIUM........  Heparin Sodium........  1,000 units/mL; 2,500  Injectable; Injection  West-Ward
                                                                                      units/mL; 5,000                               Pharmaceuticals
                                                                                      units/mL; 7,500                               International, Ltd.
                                                                                      units/mL; 10,000
                                                                                      units/mL; 15,000
                                                                                      units/mL; 20,000
                                                                                      units/mL; 5,000
                                                                                      units/0.5 mL;.
NDA 017105.........................  TRANXENE..............  Clorazepate             3.75 mg; 7.5 mg; 15    Tablet; Oral;........  Recordati Rare
                                     TRANXENE..............   Dipotassium.            mg.                   Capsule; Oral;.......   Diseases, Inc.
                                     TRANXENE SD...........  Clorazepate             3.75 mg; 7.5 mg; 15    Tablet; Oral.........
                                                              Dipotassium.            mg.
                                                             Clorazepate             11.25 mg; 22.5 mg....
                                                              Dipotassium.
NDA 017488.........................  MODICON 21............  Ethinyl Estradiol;      0.035 mg; 0.5 mg.....  Tablet; Oral.........  Ortho-McNeil
                                                              Norethindrone.                                                        Pharmaceutical, Inc.

[[Page 58258]]

 
NDA 017489.........................  ORTHO-NOVUM 1/35-21...  Ethinyl Estradiol;      0.035 mg; 1 mg.......  Tablet; Oral.........  Ortho-McNeil
                                                              Norethindrone.                                                        Pharmaceutical, Inc.
NDA 017575.........................  DTIC-DOME.............  Dacarbazine...........  100 mg/vial; 200 mg/   Injectable; Injection  Bayer Healthcare
                                                                                      vial.                                         Pharmaceuticals,
                                                                                                                                    Inc.
NDA 017576.........................  OVCON-50..............  Ethinyl Estradiol;      0.05 mg; 1 mg........  Tablet; Oral.........  Warner Chilcott Co.,
                                                              Norethindrone.                                                        LLC.
NDA 017619.........................  LOTRIMIN..............  Clotrimazole..........  1%...................  Cream; Topical.......  Schering Plough
                                                                                                                                    Healthcare Products,
                                                                                                                                    Inc.
NDA 017831.........................  DIDRONEL..............  Etidronate Disodium...  200 mg; 400 mg.......  Tablet; Oral.........  Allergan
                                                                                                                                    Pharmaceuticals
                                                                                                                                    International, Ltd.
NDA 018017.........................  BLOCADREN.............  Timolol Maleate.......  5 mg; 10 mg; 20 mg...  Tablet; Oral.........  Merck & Co., Inc.
NDA 018052.........................  GYNE-LOTRIMIN.........  Clotrimazole..........  1%...................  Cream; Vaginal.......  Bayer HealthCare,
                                                                                                                                    LLC.
NDA 018148.........................  NASALIDE..............  Flunisolide...........  0.025 mg/spray.......  Metered Spray; Nasal.  IVAX Research, Inc.
ANDA 018551........................  POTASSIUM IODIDE......  Potassium Iodide......  1 g/mL...............  Solution; Oral.......  Roxane Laboratories,
                                                                                                                                    Inc.
NDA 019004.........................  ORTHO-NOVUM 7/14-28...  Ethinyl Estradiol;      0.035 mg/0.5 mg;       Tablet; Oral.........  Ortho-McNeil
                                     ORTHO-NOVUM 7/14-21...   Norethindrone.          0.035 mg/1 mg.                                Pharmaceutical, Inc.
                                                             Ethinyl Estradiol;      0.035 mg/0.5 mg;
                                                              Norethindrone.          0.035 mg/1 mg.
NDA 019309.........................  VASOTEC...............  Enalaprilat...........  1.25 mg/mL...........  Injectable; Injection  Biovail Laboratories
                                                                                                                                    International SRL.
NDA 019621.........................  VENTOLIN..............  Albuterol Sulfate.....  Equivalent to (EQ) 2   Syrup; Oral..........  GlaxoSmithKline.
                                                                                      mg base/5 mL.
NDA 019847.........................  CIPRO.................  Ciprofloxacin.........  400 mg/40 mL; 200 mg/  Injectable; Injection  Bayer Healthcare
                                                                                      20 mL; 1200 mg/120                            Pharmaceuticals,
                                                                                      mL.                                           Inc.
NDA 019857.........................  CIPRO IN DEXTROSE 5%    Ciprofloxacin.........  200 mg/100 mL; 400 mg/ Injectable; Injection  Bayer Healthcare
                                      IN PLASTIC CONTAINER.                           200 mL.                                       Pharmaceuticals,
                                                                                                                                    Inc.
NDA 019972.........................  OCUPRESS..............  Carteolol HCl.........  1%...................  Solution/Drops;        Novartis
                                                                                                             Ophthalmic.            Pharmaceuticals,
                                                                                                                                    Corp.
NDA 020107.........................  NOVAMINE 15% SULFITE    Amino Acids...........  15%..................  Injectable; Injection  Baxter Healthcare,
                                      FREE IN PLASTIC                                                                               Corp.
                                      CONTAINER.
NDA 020207.........................  ALKERAN...............  Melphalan HCl.........  EQ 50 mg base/vial...  Injectable; Injection  Apotex, Inc.
NDA 020261.........................  LESCOL................  Fluvastatin Sodium....  EQ 20 mg base; EQ 40   Capsule; Oral........  Novartis
                                                                                      mg base.                                      Pharmaceuticals,
                                                                                                                                    Corp.
NDA 020264.........................  MEGACE................  Megestrol Acetate.....  40 mg/mL.............  Suspension; Oral.....  Bristol-Myers Squibb
                                                                                                                                    Co.
NDA 020363.........................  FAMVIR................  Famciclovir...........  125 mg; 250 mg; 500    Tablet; Oral.........  Novartis
                                                                                      mg.                                           Pharmaceuticals,
                                                                                                                                    Corp.
NDA 020792.........................  CARDIZEM..............  Diltiazem HCl.........  100 mg/vial..........  Injectable; Injection  Biovail Laboratories,
                                                                                                                                    Inc.
NDA 021127.........................  OPTIVAR...............  Azelastine HCl........  0.05%................  Solution/Drops;        Mylan Specialty, L.P.
                                                                                                             Ophthalmic.
NDA 021178.........................  GLUCOVANCE............  Glyburide; Metformin    2.5 mg/500 mg; 5 mg/   Tablet; Oral.........  Bristol-Myers Squibb
                                                              HCl.                    500 mg.                                       Co.
NDA 21277..........................  AVELOX IN SODIUM        Moxifloxacin HCl......  400 mg/250 mL........  Solution; IV Infusion  Bayer HealthCare
                                      CHLORIDE 0.8% IN                                                                              Pharmaceuticals,
                                      PLASTIC CONTAINER.                                                                            Inc.
NDA 021406.........................  FORTICAL..............  Calcitonin Salmon       200 international      Metered Spray; Nasal.  Upsher-Smith
                                                              Recombinant.            units/spray.                                  Laboratories, LLC.
NDA 021530.........................  MOBIC.................  Meloxicam.............  7.5 mg/5 mL..........  Suspension; Oral.....  Boehringer Ingelheim
                                                                                                                                    Pharmaceuticals,
                                                                                                                                    Inc.
NDA 021689.........................  NEXIUM IV.............  Esomeprazole Sodium...  EQ 20 mg base/vial...  Injectable;            AstraZeneca
                                                                                                             Intravenous.           Pharmaceuticals LP.
NDA 022033.........................  LUVOX CR..............  Fluvoxamine Maleate...  100 mg; 150 mg.......  Extended-Release       Jazz Pharmaceuticals,
                                                                                                             Capsule; Oral.         Inc.
NDA 050299.........................  NILSTAT...............  Nystatin..............  100,000 units/mL.....  Suspension; Oral.....  Glenmark Generics
                                                                                                                                    Inc., USA.
NDA 050484.........................  CERUBIDINE............  Daunorubicin HCl......  EQ 20 mg base/vial...  Injectable; Injection  Wyeth Research.
NDA 050662.........................  BIAXIN................  Clarithromycin........  250 mg; 500 mg.......  Tablet; Oral.........  AbbVie, Inc.
ANDA 060076........................  STREPTOMYCIN SULFATE..  Streptomycin Sulfate..  EQ 1g base/vial; EQ 5  Injectable; Injection  Pfizer, Inc.
                                                                                      g base/vial.

[[Page 58259]]

 
ANDA 080472........................  HYTONE................  Hydrocortisone........  1%, 2.5%.............  Cream; Topical.......  Valeant
                                                                                                                                    Pharmaceuticals
                                                                                                                                    North America, LLC.
ANDA 080473........................  HYTONE................  Hydrocortisone........  1%; 2.5%.............  Lotion; Topical......  Valeant
                                                                                                                                    Pharmaceuticals
                                                                                                                                    North America, LLC.
ANDA 080474........................  HYTONE................  Hydrocortisone........  1%, 2.5%.............  Ointment; Topical....  Dermik Laboratories,
                                                                                                                                    Inc.
NDA 202088.........................  SUPRENZA..............  Phentermine HCl.......  15 mg; 30 mg; 37.5 mg  Orally Disintegrating  Citius
                                                                                                             Tablet; Oral.          Pharmaceuticals,
                                                                                                                                    LLC.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has 
determined that the drug products listed were not withdrawn from sale 
for reasons of safety or effectiveness. Accordingly, the Agency will 
continue to list the drug products in the ``Discontinued Drug Product 
List'' section of the Orange Book. The ``Discontinued Drug Product 
List'' identifies, among other items, drug products that have been 
discontinued from marketing for reasons other than safety or 
effectiveness.
    Approved ANDAs that refer to the NDAs and ANDAs listed are 
unaffected by the discontinued marketing of the products subject to 
those NDAs and ANDAs. Additional ANDAs that refer to these products may 
also be approved by the Agency if they comply with relevant legal and 
regulatory requirements. If FDA determines that labeling for these drug 
products should be revised to meet current standards, the Agency will 
advise ANDA applicants to submit such labeling.

    Dated: November 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25187 Filed 11-16-18; 8:45 am]
 BILLING CODE 4164-01-P


