[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Milligrams/Vial, and Other Drug Products Were Not Withdrawn From Sale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withdrawn from sale for reasons of safety or effectiveness.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