Determination That CLAFORAN (Cefotaxime Sodium) for Injection, 500 Milligrams/Vial, 1 Gram/Vial, 2 Grams/Vial and 10 Grams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 31873-31874 [2019-14172]
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Federal Register / Vol. 84, No. 128 / Wednesday, July 3, 2019 / Notices
Application No.
Drug
NDA 019292 ............
MD–76R (diatrizoate meglumine and diatrizoate sodium) Injection, 66%/10%.
Maxair Autohaler (pirbuterol acetate inhalation aerosol), EQ
0.2 mg base/inhalation.
DepoCyt (cytarabine liposome) Injection, 10 mg/mL ............
NDA 020014 ............
NDA 021041 ............
NDA 021338 ............
NDA 022396 ............
NDA 203568 ............
Kynamro (mipomersen sodium) Injection, 200 mg/mL .........
NDA 022222 ............
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of August 2,
2019. Approval of each entire
application is withdrawn, including any
strengths or products 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 August 2, 2019 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: June 28, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–14219 Filed 7–2–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–P–1366]
jspears on DSK30JT082PROD with NOTICES
Applicant
Ionsys (fentanyl iontophoresis transdermal system), 40
mcg/activation.
Fosamax (alendronate sodium) Oral Solution, EQ 70 mg
base/75 mL.
Ultresa (pancrelipase (amylase, lipase, protease)), Delayed-Release Capsules, 8,000 USP Units/4,000 USP
Units/8,000 USP Units and 27,600 USP Units/13,800
USP Units/27,600 USP Units, and 41,400 USP Units/
20,700 USP Units/41,400 USP Units, and 46,000 USP
Units/23,000 USP Units/46,000 USP Units.
Dyloject (diclofenac sodium) Injection, 37.5 mg/mL .............
NDA 021575 ............
Determination That CLAFORAN
(Cefotaxime Sodium) for Injection, 500
Milligrams/Vial, 1 Gram/Vial, 2 Grams/
Vial and 10 Grams/Vial, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
19:23 Jul 02, 2019
Jkt 247001
Liebel-Flarsheim Co. LLC.
Bausch Health US, LLC.
Pacira Pharmaceuticals, Inc., 5 Sylvan Way, Suite 300,
Parsippany, NJ 07054.
The Medicines Co., 8 Sylvan Way, Parsippany, NJ 07054.
Merck Sharp & Dohme Corp., 1 Merck Dr., P.O. Box 100,
Whitehouse Station, NJ 08889–0100.
Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ 07940.
Javelin Pharmaceuticals, Inc., a subsidiary of Hospira Inc.,
275 North Field Dr., Dept. 0392, Bldg. H1–3S, Lake Forest, IL 60045.
Kastle Therapeutics, 181 West Madison St., Suite 300, Chicago, IL 60602.
The Food and Drug
Administration (FDA or Agency) has
determined that CLAFORAN
(cefotaxime sodium) for injection, 500
milligrams (mg)/vial, 1 gram (g)/vial, 2
g/vial and 10 g/vial, was 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
this drug product, and it will allow FDA
to continue to approve ANDAs that refer
to the product as long as they meet
relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT: Beth
Holck, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6217, Silver Spring,
MD 20993–0002, 240–402–7133.
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 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
SUMMARY:
PO 00000
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31873
Fmt 4703
Sfmt 4703
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are 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).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
CLAFORAN (cefotaxime sodium) for
injection, 500 mg/vial, 1 g/vial, 2 g/vial
and 10 g/vial, is the subject of NDA
050547, held by US Pharmaceutical
Holdings II LLC, and initially approved
on March 11, 1981. CLAFORAN is
indicated for the treatment of patients
with serious bacterial infections in eight
different organ systems caused by
susceptible strains of microorganisms,
as specified in the labeling.
In a letter dated February 9, 2018, US
Pharmaceutical Holdings II LLC notified
FDA that CLAFORAN (cefotaxime for
injection) 500 mg/vial, 1 g/vial, 2 g/vial
and 10 g/vial was being discontinued,
and FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
E:\FR\FM\03JYN1.SGM
03JYN1
jspears on DSK30JT082PROD with NOTICES
31874
Federal Register / Vol. 84, No. 128 / Wednesday, July 3, 2019 / Notices
Cardinal Health Regulatory Sciences
submitted a citizen petition dated
January 31, 2019 (Docket No. FDA–
2019–P–1366), under 21 CFR 10.30,
requesting that the Agency determine
whether CLAFORAN (cefotaxime
sodium) for injection, 500 mg/vial, 1 g/
vial, 2 g/vial and 10 g/vial, was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that CLAFORAN (cefotaxime
sodium) for injection, 500 mg/vial, 1 g/
vial, 2 g/vial and 10 g/vial was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that CLAFORAN (cefotaxime
sodium) for injection, 500 mg/vial, 1 g/
vial, 2 g/vial and 10 g/vial was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
CLAFORAN (cefotaxime sodium) for
injection, 500 mg/vial, 1 g/vial, 2 g/vial
and 10 g/vial from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list CLAFORAN (cefotaxime
sodium) for injection, 500 mg/vial, 1 g/
vial, 2 g/vial and 10 g/vial, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: June 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–14172 Filed 7–2–19; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
19:23 Jul 02, 2019
Jkt 247001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3208]
DHL Laboratories Inc.; Withdrawal of
Approval of a New Drug Application for
Dextrose 5% Injection in Plastic
Container, 5 Grams/100 Milliliters
AGENCY:
Food and Drug Administration,
concerning the legal status of the drug
product. Therefore, under these
findings, approval of NDA 019971, and
all amendments and supplements
thereto, is hereby withdrawn as of July
3, 2019.
Dated: June 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–14137 Filed 7–2–19; 8:45 am]
BILLING CODE 4164–01–P
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of new drug application (NDA)
019971 for Dextrose 5% Injection in
Plastic Container, 5 grams (g)/100
milliliters (mL), held by DHL
Laboratories Inc., 155 Medical Science
Dr., Union, SC 23979. The basis for the
withdrawal is that the holder of the
NDA has repeatedly failed to file
required annual reports for the NDA.
DATES: Approval is withdrawn as of July
3, 2019.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: The
holder of an approved application to
market a new drug for human use is
required to submit annual reports to
FDA concerning its approved
application in accordance with § 314.81
(21 CFR 314.81).
In the Federal Register of August 29,
2018 (83 FR 44056), FDA published a
notice offering an opportunity for a
hearing (NOOH) on a proposal to
withdraw approval of NDA 019971
because DHL Laboratories Inc. had
failed to submit required annual reports
for the NDA. DHL Laboratories Inc. did
not respond to the NOOH. Failure to file
a written notice of participation and
request for hearing as required by
§ 314.200 (21 CFR 314.200) constitutes
an election by the holder of the NDA not
to make use of the opportunity for a
hearing concerning the proposal to
withdraw approval of the NDA and a
waiver of any contentions concerning
the legal status of the drug product. FDA
is withdrawing approval of NDA 019971
for Dextrose 5% Injection in Plastic
Container, 5 g/100 mL.
FDA finds that DHL Laboratories Inc.
has repeatedly failed to submit reports
required by § 314.81. In addition, under
§ 314.200, FDA finds DHL Laboratories
Inc. has waived any contentions
SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1114]
Pharmaceutical Distribution Supply
Chain Pilot Projects; Reopening of
Comment Period; Request for
Information
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of comment
period; request for information.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
reopening the comment period for the
notices (requests for information) that
published in the Federal Register of
April 15, 2016, and April 28, 2017. FDA
is requesting comments regarding issues
related to utilizing the product identifier
for product tracing, improving the
technical capabilities of the supply
chain, and identifying system attributes
that are necessary to implement the
requirements established under the
Drug Supply Chain Security Act
(DSCSA). The information gathered
from reopening of the comment period
will allow supply chain stakeholders to
share information about relevant
piloting activities that are conducted
outside of FDA’s DSCSA Pilot Project
Program to inform DSCSA
implementation by FDA and supply
chain stakeholders.
DATES: FDA is reopening the comment
period on the notices (requests for
information) published April 15, 2016
(81 FR 22279), and April 28, 2017 (82
FR 19737). Submit either electronic or
written comments by June 28, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before June 28, 2022.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 28, 2022. Comments
received by mail/hand delivery/courier
SUMMARY:
E:\FR\FM\03JYN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Pages 31873-31874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14172]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-P-1366]
Determination That CLAFORAN (Cefotaxime Sodium) for Injection,
500 Milligrams/Vial, 1 Gram/Vial, 2 Grams/Vial and 10 Grams/Vial, Was
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 CLAFORAN (cefotaxime sodium) for injection, 500
milligrams (mg)/vial, 1 gram (g)/vial, 2 g/vial and 10 g/vial, was 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
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Beth Holck, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002, 240-402-7133.
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 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 known generally as the ``Orange
Book.'' Under FDA regulations, drugs are 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).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
CLAFORAN (cefotaxime sodium) for injection, 500 mg/vial, 1 g/vial,
2 g/vial and 10 g/vial, is the subject of NDA 050547, held by US
Pharmaceutical Holdings II LLC, and initially approved on March 11,
1981. CLAFORAN is indicated for the treatment of patients with serious
bacterial infections in eight different organ systems caused by
susceptible strains of microorganisms, as specified in the labeling.
In a letter dated February 9, 2018, US Pharmaceutical Holdings II
LLC notified FDA that CLAFORAN (cefotaxime for injection) 500 mg/vial,
1 g/vial, 2 g/vial and 10 g/vial was being discontinued, and FDA moved
the drug product to the ``Discontinued Drug Product List'' section of
the Orange Book.
[[Page 31874]]
Cardinal Health Regulatory Sciences submitted a citizen petition
dated January 31, 2019 (Docket No. FDA-2019-P-1366), under 21 CFR
10.30, requesting that the Agency determine whether CLAFORAN
(cefotaxime sodium) for injection, 500 mg/vial, 1 g/vial, 2 g/vial and
10 g/vial, was withdrawn from sale for reasons of safety or
effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that CLAFORAN (cefotaxime sodium) for injection,
500 mg/vial, 1 g/vial, 2 g/vial and 10 g/vial was not withdrawn for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that CLAFORAN (cefotaxime sodium)
for injection, 500 mg/vial, 1 g/vial, 2 g/vial and 10 g/vial was
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of CLAFORAN
(cefotaxime sodium) for injection, 500 mg/vial, 1 g/vial, 2 g/vial and
10 g/vial from sale. We have also independently evaluated relevant
literature and data for possible postmarketing adverse events. We have
found no information that would indicate that this drug product was
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list CLAFORAN (cefotaxime
sodium) for injection, 500 mg/vial, 1 g/vial, 2 g/vial and 10 g/vial,
in the ``Discontinued Drug Product List'' section of the Orange Book.
The ``Discontinued Drug Product List'' delineates, among other items,
drug products that have been discontinued from marketing for reasons
other than safety or effectiveness. FDA will not begin procedures to
withdraw approval of approved ANDAs that refer to this drug product.
Additional ANDAs for this drug product may also be approved by the
Agency as long as they meet all other legal and regulatory requirements
for the approval of ANDAs. If FDA determines that labeling for this
drug product should be revised to meet current standards, the Agency
will advise ANDA applicants to submit such labeling.
Dated: June 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14172 Filed 7-2-19; 8:45 am]
BILLING CODE 4164-01-P
