Determination That REGITINE (Phentolamine Mesylate) Injection, 5 Milligrams/Vial, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Federal Register, Volume 83 Issue 223 (Monday, November 19, 2018)

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Determination That REGITINE (Phentolamine Mesylate) Injection, 5 Milligrams/Vial, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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

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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.

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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