Liebel-Flarsheim Company LLC, et al.; Withdrawal of Approval of 11 New Drug Applications, 31872-31873 [2019-14219]
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Federal Register / Vol. 84, No. 128 / Wednesday, July 3, 2019 / Notices
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Dated: June 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–14141 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–N–2040]
Liebel-Flarsheim Company LLC, et al.;
Withdrawal of Approval of 11 New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 11 new drug
applications (NDAs) from multiple
applicants. The applicants notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of
August 2, 2019.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137.
SUPPLEMENTARY INFORMATION: The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
SUMMARY:
Application No.
Drug
Applicant
NDA 016983 ............
Conray 30 (iothalamate meglumine) Injection, 30% .............
NDA 018972 ............
Cordarone (amiodarone HCl) Tablets, 200 mg .....................
NDA 019009 ............
Maxair Inhaler (pirbuterol acetate inhalation aerosol), equivalent to (EQ) 0.2 mg base/inhalation.
Liebel-Flarsheim Co. LLC, 1034 South Brentwood Blvd.,
Suite 800, Richmond Heights, MO 63117.
Wyeth Pharmaceuticals LLC, P.O. Box 8299, Philadelphia,
PA 19101–8299.
Bausch Health US, LLC, 400 Somerset Corporate Blvd.,
Bridgewater, NH 08807.
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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.
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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
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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.
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]]>Agencies
[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Pages 31872-31873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14219]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2040]
Liebel-Flarsheim Company LLC, et al.; Withdrawal of Approval of
11 New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 11 new drug applications (NDAs) from multiple
applicants. The applicants notified the Agency in writing that the drug
products were no longer marketed and requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of August 2, 2019.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process in Sec. 314.150(c) (21 CFR 314.150(c)). The applicants have
also, by their requests, waived their opportunity for a hearing.
Withdrawal of approval of an application or abbreviated application
under Sec. 314.150(c) is without prejudice to refiling.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 016983................ Conray 30 Liebel-Flarsheim Co.
(iothalamate LLC, 1034 South
meglumine) Brentwood Blvd.,
Injection, 30%. Suite 800, Richmond
Heights, MO 63117.
NDA 018972................ Cordarone (amiodarone Wyeth Pharmaceuticals
HCl) Tablets, 200 mg. LLC, P.O. Box 8299,
Philadelphia, PA
19101-8299.
NDA 019009................ Maxair Inhaler Bausch Health US,
(pirbuterol acetate LLC, 400 Somerset
inhalation aerosol), Corporate Blvd.,
equivalent to (EQ) Bridgewater, NH
0.2 mg base/ 08807.
inhalation.
[[Page 31873]]
NDA 019292................ MD-76R (diatrizoate Liebel-Flarsheim Co.
meglumine and LLC.
diatrizoate sodium)
Injection, 66%/10%.
NDA 020014................ Maxair Autohaler Bausch Health US,
(pirbuterol acetate LLC.
inhalation aerosol),
EQ 0.2 mg base/
inhalation.
NDA 021041................ DepoCyt (cytarabine Pacira
liposome) Injection, Pharmaceuticals,
10 mg/mL. Inc., 5 Sylvan Way,
Suite 300,
Parsippany, NJ
07054.
NDA 021338................ Ionsys (fentanyl The Medicines Co., 8
iontophoresis Sylvan Way,
transdermal system), Parsippany, NJ
40 mcg/activation. 07054.
NDA 021575................ Fosamax (alendronate Merck Sharp & Dohme
sodium) Oral Corp., 1 Merck Dr.,
Solution, EQ 70 mg P.O. Box 100,
base/75 mL. Whitehouse Station,
NJ 08889-0100.
NDA 022222................ Ultresa (pancrelipase Allergan Sales, LLC,
(amylase, lipase, 5 Giralda Farms,
protease)), Delayed- Madison, NJ 07940.
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.
NDA 022396................ Dyloject (diclofenac Javelin
sodium) Injection, Pharmaceuticals,
37.5 mg/mL. Inc., a subsidiary
of Hospira Inc., 275
North Field Dr.,
Dept. 0392, Bldg. H1-
3S, Lake Forest, IL
60045.
NDA 203568................ Kynamro (mipomersen Kastle Therapeutics,
sodium) Injection, 181 West Madison
200 mg/mL. St., Suite 300,
Chicago, IL 60602.
------------------------------------------------------------------------
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
