Determination That REGITINE (Phentolamine Mesylate) Injection, 5 Milligrams/Vial, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 58257-58259 [2018-25187]
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Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices
and thus is not a regulatory action for
the purposes of E.O. 13771.
In accordance with the provisions of
Executive Order 12866, this notice was
reviewed by the Office of Management
and Budget.
Dated: October 19, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2018–25012 Filed 11–16–18; 8:45 am]
BILLING CODE 4120–01–P
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Products Were Not Withdrawn From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.
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in this document were not withdrawn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
SUMMARY:
Application No.
Drug name
Active ingredient(s)
NDA
REGITINE .....................
008278.
NDA
KAYEXALATE ...............
011287.
NDA
PROLIXIN ......................
011751.
NDA
LIBRIUM ........................
012249.
NDA
PERMITIL ......................
016008.
khammond on DSK30JT082PROD with NOTICES
NDA
PROLIXIN ENANTHATE
016110.
NDA
HEPARIN SODIUM .......
017007.
NDA
TRANXENE ...................
017105. TRANXENE ...................
TRANXENE SD .............
NDA
MODICON 21 ................
017488.
VerDate Sep<11>2014
17:20 Nov 16, 2018
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,
Stacy.Kane@fda.hhs.gov.
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.
58257
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 § 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.
Strength(s)
Dosage form/route
Phentolamine Mesylate
5 milligrams (mg)/vial ....
Injectable; Injection .......
Sodium Polystyrene
Sulfonate.
Fluphenazine Hydrochloride (HCl).
Fluphenazine HCl ..........
Chlordiazepoxide HCl ...
453.6 grams (g)/bottle ...
Powder; Oral, Rectal .....
2.5 mg/milliliter (mL) ......
1 mg; 2.5 mg; 5 mg; 10
mg.
5 mg; 10 mg; 25 mg .....
Injectable; Injection; ......
Tablet; Oral ...................
Capsule; Oral ................
Fluphenazine HCl ..........
5 mg/mL ........................
Concentrate; Oral ..........
Fluphenazine Enanthate
25 mg/mL ......................
Injectable; Injection .......
Heparin Sodium ............
1,000 units/mL; 2,500
units/mL; 5,000 units/
mL; 7,500 units/mL;
10,000 units/mL;
15,000 units/mL;
20,000 units/mL;
5,000 units/0.5 mL;.
3.75 mg; 7.5 mg; 15 mg
3.75 mg; 7.5 mg; 15 mg
11.25 mg; 22.5 mg ........
Injectable; Injection .......
Tablet; Oral; ..................
Capsule; Oral; ...............
Tablet; Oral ...................
Recordati Rare Diseases, Inc.
0.035 mg; 0.5 mg ..........
Tablet; Oral ...................
Ortho-McNeil Pharmaceutical, Inc.
Clorazepate
Dipotassium.
Clorazepate
Dipotassium.
Clorazepate
Dipotassium.
Ethinyl Estradiol;
Norethindrone.
Jkt 247001
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
E:\FR\FM\19NON1.SGM
19NON1
Applicant
Novartis Pharmaceuticals Corp.
Concordia Pharmaceuticals, Inc.
Bristol-Myers Squibb
Co.
Valeant Pharmaceuticals
North America, LLC.
Schering Corp., Subsidiary of Schering
Plough, Corp.
Bristol-Myers Squibb
Co.
West-Ward Pharmaceuticals International,
Ltd.
58258
Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices
Application No.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
Applicant
NDA
017489.
NDA
017575.
NDA
017576.
NDA
017619.
ORTHO–NOVUM 1/35–
21.
DTIC–DOME .................
Ethinyl Estradiol;
Norethindrone.
Dacarbazine ..................
0.035 mg; 1 mg .............
Tablet; Oral ...................
100 mg/vial; 200 mg/vial
Injectable; Injection .......
OVCON–50 ...................
Ethinyl Estradiol;
Norethindrone.
Clotrimazole ..................
0.05 mg; 1 mg ...............
Tablet; Oral ...................
1% .................................
Cream; Topical ..............
NDA
DIDRONEL ....................
017831.
Etidronate Disodium ......
200 mg; 400 mg ............
Tablet; Oral ...................
NDA
018017.
NDA
018052.
NDA
018148.
ANDA
018551.
NDA
019004.
BLOCADREN ................
Timolol Maleate .............
5 mg; 10 mg; 20 mg .....
Tablet; Oral ...................
Ortho-McNeil Pharmaceutical, Inc.
Bayer Healthcare Pharmaceuticals, Inc.
Warner Chilcott Co.,
LLC.
Schering Plough
Healthcare Products,
Inc.
Allergan Pharmaceuticals International,
Ltd.
Merck & Co., Inc.
GYNE–LOTRIMIN .........
Clotrimazole ..................
1% .................................
Cream; Vaginal .............
Bayer HealthCare, LLC.
NASALIDE .....................
Flunisolide .....................
0.025 mg/spray .............
Metered Spray; Nasal ...
IVAX Research, Inc.
POTASSIUM IODIDE ....
Potassium Iodide ...........
1 g/mL ...........................
Solution; Oral ................
ORTHO–NOVUM 7/14–
28.
ORTHO–NOVUM 7/14–
21.
VASOTEC .....................
Ethinyl Estradiol;
Norethindrone.
Ethinyl Estradiol;
Norethindrone.
Enalaprilat .....................
0.035 mg/0.5 mg; 0.035
mg/1 mg.
0.035 mg/0.5 mg; 0.035
mg/1 mg.
1.25 mg/mL ...................
Tablet; Oral ...................
Roxane Laboratories,
Inc.
Ortho-McNeil Pharmaceutical, Inc.
Albuterol Sulfate ............
Equivalent to (EQ) 2 mg
base/5 mL.
400 mg/40 mL; 200 mg/
20 mL; 1200 mg/120
mL.
200 mg/100 mL; 400
mg/200 mL.
Syrup; Oral ....................
Carteolol HCl .................
1% .................................
Amino Acids ..................
LOTRIMIN .....................
khammond on DSK30JT082PROD with NOTICES
NDA
019309.
NDA
VENTOLIN ....................
019621.
NDA
CIPRO ...........................
019847.
NDA
CIPRO IN DEXTROSE
019857.
5% IN PLASTIC
CONTAINER.
NDA
OCUPRESS ..................
019972.
NDA
NOVAMINE 15% SUL020107.
FITE FREE IN PLASTIC CONTAINER.
NDA
ALKERAN ......................
020207.
NDA
LESCOL ........................
020261.
NDA
MEGACE .......................
020264.
NDA
FAMVIR .........................
020363.
NDA
CARDIZEM ....................
020792.
NDA
OPTIVAR .......................
021127.
NDA
GLUCOVANCE .............
021178.
NDA
AVELOX IN SODIUM
21277.
CHLORIDE 0.8% IN
PLASTIC CONTAINER.
NDA
FORTICAL .....................
021406.
NDA
MOBIC ...........................
021530.
NDA
NEXIUM IV ....................
021689.
NDA
LUVOX CR ....................
022033.
NDA
NILSTAT ........................
050299.
NDA
CERUBIDINE ................
050484.
NDA
BIAXIN ...........................
050662.
ANDA
STREPTOMYCIN SUL060076.
FATE.
VerDate Sep<11>2014
17:20 Nov 16, 2018
Ciprofloxacin ..................
Injectable; Injection .......
Biovail Laboratories
International SRL.
GlaxoSmithKline.
Injectable; Injection .......
Bayer Healthcare Pharmaceuticals, Inc.
Injectable; Injection .......
Bayer Healthcare Pharmaceuticals, Inc.
15% ...............................
Solution/Drops; Ophthalmic.
Injectable; Injection .......
Novartis Pharmaceuticals, Corp.
Baxter Healthcare, Corp.
Melphalan HCl ...............
EQ 50 mg base/vial ......
Injectable; Injection .......
Apotex, Inc.
Fluvastatin Sodium ........
EQ 20 mg base; EQ 40
mg base.
40 mg/mL ......................
Capsule; Oral ................
Novartis Pharmaceuticals, Corp.
Bristol-Myers Squibb
Co.
Novartis Pharmaceuticals, Corp.
Biovail Laboratories, Inc.
Ciprofloxacin ..................
Megestrol Acetate .........
Famciclovir ....................
Suspension; Oral ...........
Diltiazem HCl ................
125 mg; 250 mg; 500
mg.
100 mg/vial ....................
Azelastine HCl ...............
0.05% ............................
Glyburide; Metformin
HCl.
Moxifloxacin HCl ...........
2.5 mg/500 mg; 5 mg/
500 mg.
400 mg/250 mL .............
Calcitonin Salmon Recombinant.
Meloxicam .....................
200 international units/
spray.
7.5 mg/5 mL ..................
Suspension; Oral ...........
Esomeprazole Sodium ..
EQ 20 mg base/vial ......
Injectable; Intravenous ..
Fluvoxamine Maleate ....
100 mg; 150 mg ............
Nystatin .........................
100,000 units/mL ...........
Extended-Release Capsule; Oral.
Suspension; Oral ...........
Daunorubicin HCl ..........
EQ 20 mg base/vial ......
Injectable; Injection .......
Upsher-Smith Laboratories, LLC.
Boehringer Ingelheim
Pharmaceuticals, Inc.
AstraZeneca Pharmaceuticals LP.
Jazz Pharmaceuticals,
Inc.
Glenmark Generics Inc.,
USA.
Wyeth Research.
Clarithromycin ...............
250 mg; 500 mg ............
Tablet; Oral ...................
AbbVie, Inc.
Streptomycin Sulfate .....
EQ 1g base/vial; EQ 5 g
base/vial.
Injectable; Injection .......
Pfizer, Inc.
Jkt 247001
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Tablet; Oral ...................
Injectable; Injection .......
Solution/Drops; Ophthalmic.
Tablet; Oral ...................
Solution; IV Infusion ......
Metered Spray; Nasal ...
E:\FR\FM\19NON1.SGM
19NON1
Mylan Specialty, L.P.
Bristol-Myers Squibb
Co.
Bayer HealthCare Pharmaceuticals, Inc.
Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices
Application No.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
Applicant
ANDA
080472.
ANDA
080473.
ANDA
080474.
NDA
202088.
HYTONE .......................
Hydrocortisone ..............
1%, 2.5% .......................
Cream; Topical ..............
HYTONE .......................
Hydrocortisone ..............
1%; 2.5% .......................
Lotion; Topical ...............
HYTONE .......................
Hydrocortisone ..............
1%, 2.5% .......................
Ointment; Topical ..........
SUPRENZA ...................
Phentermine HCl ...........
15 mg; 30 mg; 37.5 mg
Orally Disintegrating
Tablet; Oral.
Valeant Pharmaceuticals
North America, LLC.
Valeant Pharmaceuticals
North America, LLC.
Dermik Laboratories,
Inc.
Citius Pharmaceuticals,
LLC.
FDA has reviewed its records and,
under § 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3771]
Report on the Performance of Drug
and Biologics Firms in Conducting
Postmarketing Requirements and
Commitments; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
khammond on DSK30JT082PROD with NOTICES
58259
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the
Agency’s annual report entitled ‘‘Report
on the Performance of Drug and
Biologics Firms in Conducting
Postmarketing Requirements and
Commitments.’’ Under the Federal
SUMMARY:
VerDate Sep<11>2014
17:20 Nov 16, 2018
Jkt 247001
Food, Drug, and Cosmetic Act (FD&C
Act), FDA is required to report annually
on the status of postmarketing
requirements (PMRs) and postmarketing
commitments (PMCs) required of, or
agreed upon by, application holders of
approved drug and biological products.
The report on the status of the studies
and clinical trials that applicants have
agreed to, or are required to, conduct is
on the FDA’s ‘‘Postmarketing
Requirements and Commitments:
Reports’’ web page (https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Post-marketing
PhaseIVCommitments/ucm064436.htm).
FOR FURTHER INFORMATION CONTACT:
Cathryn C. Lee, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6484,
Silver Spring, MD 20993–0002, 301–
796–0700; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
Section 506B(c) of the FD&C Act (21
U.S.C. 356b(c)) requires FDA to publish
an annual report on the status of
postmarketing study commitments that
applicants have committed to, or are
required to conduct, and for which
annual status reports have been
submitted.
Under §§ 314.81(b)(2)(vii) and 601.70
(21 CFR 314.81(b)(2)(vii) and 601.70),
applicants of approved drugs and
licensed biologics are required to submit
annually a report on the status of each
clinical safety, clinical efficacy, clinical
pharmacology, and nonclinical
toxicology study or clinical trial either
required by FDA (PMRs) or that they
have committed to conduct (PMCs),
either at the time of approval or after
approval of their new drug application,
abbreviated new drug application, or
biologics license application. The status
of PMCs concerning chemistry,
manufacturing, and production controls
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
and the status of other studies or
clinical trials conducted on an
applicant’s own initiative are not
required to be reported under
§§ 314.81(b)(2)(vii) and 601.70 and are
not addressed in this report.
Furthermore, section 505(o)(3)(E) of the
FD&C Act (21 U.S.C. 355(o)(3)(E))
requires that applicants report
periodically on the status of each
required study or clinical trial and each
study or clinical trial ‘‘otherwise
undertaken . . . to investigate a safety
issue . . .’’
An applicant must report on the
progress of the PMR/PMC on the
anniversary of the drug product’s
approval1 until the PMR/PMC is
completed or terminated and FDA
determines that the PMR/PMC has been
fulfilled or that the PMR/PMC is either
no longer feasible or would no longer
provide useful information.
II. Fiscal Year 2017 Report
With this notice, FDA is announcing
the availability of the Agency’s annual
report entitled ‘‘Report on the
Performance of Drug and Biologics
Firms in Conducting Postmarketing
Requirements and Commitments.’’
Information in this report covers any
PMR/PMC that was established, in
writing, at the time of approval or after
approval of an application or a
supplement to an application, and
summarizes the status of PMRs/PMCs in
fiscal year (FY) 2017 (i.e., as of
September 30, 2017). Information
summarized in the report reflects
combined data from the Center for Drug
Evaluation and Research and the Center
for Biologics Evaluation and Research
and includes the following: (1) The
number of applicants with open PMRs/
PMCs; (2) the number of open PMRs/
PMCs; (3) the timeliness of applicant
submission of the annual status reports
1 An applicant must submit an annual status
report on the progress of each open PMR/PMC
within 60 days of the anniversary date of U.S.
approval of the original application or on an
alternate reporting date that was granted by FDA in
writing. Some applicants have requested and been
granted by FDA alternate annual reporting dates to
facilitate harmonized reporting across multiple
applications.
E:\FR\FM\19NON1.SGM
19NON1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
