Department of Health and Human Services, Supply Service Center et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications, 44185-44187 [2017-20107]
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44185
Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices
little research on ASD in adolescence
and adulthood.
While there is research showing that
the majority of ASD diagnoses made in
early childhood are retained in
adolescence with mostly stable in
symptom severity, there are major gaps
in our understanding of the health,
functioning, and experiences of
adolescents with ASD and other
developmental disabilities. Many of
these topics are especially relevant to
public health: Adolescents and adults
with ASD have been shown to have
frequent health problems, high
healthcare utilization and specialized
service needs, high caregiving burden,
require substantial supports to perform
daily activities, are likely to be bullied,
or isolated from society, and are likely
to have food allergies or put on
restrictive diets of questionable benefit.
Many of these problems emerge after
early childhood, and more studies are
needed to estimate the frequency,
severity, and predictive factors for these
important outcomes in diverse cohorts
of individuals with autism and other
developmental conditions.
SEED Teen is a follow-up study of
children who participated in the first
phase of the SEED case-control study
(SEED 1) in 2007–2011 when they were
2 to 5 years of age. SEED includes one
of the largest cohorts of children
assembled with ASD. Children will be
identified from four SEED sites in
Georgia, Maryland, North Carolina, and
Pennsylvania. Three groups of children
will be included: Children with ASD,
children with other developmental
(non-ASD) conditions (DD comparison
group), and children from the general
population who were initially sampled
from birth records (POP comparison
group).
The children and parents previously
enrolled in SEED 1 represent a unique
opportunity to better understand the
long term trajectory of children
identified as having ASD at early ages.
Mothers or other primary caregivers
who participated in SEED 1 will be recontacted when their child is 13–17
years of age and asked to complete two
self-administered questionnaires (SEED
Teen Health and Development Survey
and the Social Responsiveness Scale)
about their child’s health, development,
education, and current functioning.
Information from this study will allow
researchers to assess the long term
health and functioning of children with
ASD and other developmental
disabilities, family impacts associated
with ASD and other DDs, and service
needs and use associated with having
and ASD and other DDs, particularly
during the teen years.
We estimate that 1,410 SEED families
are potentially eligible to participate in
SEED Teen. Reading the letter and other
materials in the invitation mailing will
take approximately five minutes. We
estimate that a minimum of 60% of
parents/caregivers will be sent the
invitation mailing or will be
successfully contacted and participate
in the invitation call (approximately 15
minutes). We estimate that 80% of the
families who participate in the
invitation call will meet the eligibility
criteria for SEED Teen and 70% of those
will enroll in SEED Teen. We assume all
enrolled families will complete the
follow-up call to confirm data collection
packet receipt (approximately 10
minutes) and will review the materials
in the data collection packet. Finally,
we estimate that 90% of enrolled
parents/caregivers will complete two
self-administered questionnaires (SEED
Teen Health and Development Survey
and the Social Responsiveness Scale)
and two supplemental consent forms.
The two questionnaires will take
approximately 60 minutes to complete,
plus an additional 5 minutes to read and
sign the informed consent. Therefore,
we estimate the total burden hours are
303.
There are no costs to participants
other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Form name
Eligible families who were enrolled in SEED 1
Eligible families who were enrolled in SEED 1
Families who agreed to participate in SEED
Teen.
Families who agreed to participate in SEED
Teen.
Families who agreed to participate in SEED
Teen.
Families who agreed to participate in SEED
Teen.
Families who agreed to participate in SEED
Teen.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Type of respondents
Invitation Packet .............................................
Invitation Call Script .......................................
Follow-up Call ................................................
470
282
158
1
1
1
5/60
15/60
10/60
Data Collection Packet ...................................
158
1
5/60
SEED Teen Health and Development Survey
142
1
40/60
Social Responsive-ness Scale .......................
142
1
20/60
Supplemental Consent forms .........................
142
1
5/60
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2017–N–5526]
Department of Health and Human
Services, Supply Service Center et al.;
Withdrawal of Approval of 27
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
17:52 Sep 20, 2017
Jkt 241001
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of 27 abbreviated new drug
applications (ANDAs) from multiple
applicants. The holders of the
applications notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
SUMMARY:
Food and Drug Administration
[FR Doc. 2017–20067 Filed 9–20–17; 8:45 am]
BILLING CODE 4163–18–P
ACTION:
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Applied Date: October 23, 2017.
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44186
Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices
FOR FURTHER INFORMATION CONTACT:
The
holders of the applications listed in
table 1 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
SUPPLEMENTARY INFORMATION:
Trang Tran, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1671, Silver Spring,
MD 20993–0002, 240–402–7945.
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an abbreviated
application under § 314.150(c) is
without prejudice to refiling.
TABLE 1
Application No.
Drug
Applicant
ANDA 061071 ......................
Tetracycline Hydrochloride (HCl) Tablets, 250 milligrams (mg).
ANDA 062279 ......................
Grifulvin V (griseofulvin microsize) Tablets USP,125
mg, 250 mg, and 500 mg.
Cephalexin Capsules, 250 mg and 500 mg ...................
Department of Health and Human Services, Supply
Service Center, PSC Bldg. 14 Boiler House Rd.,
Perry Point, MD 21902.
Valeant Pharmaceuticals North America, LLC, 400
Somerset Corporate Blvd., Bridgewater, NJ 08807.
Department of Health and Human Services, Supply
Service Center, PSC Bldg. 14 Boiler House Rd.,
Perry Point, MD 21902.
Merck Sharp & Dohme Corp., Subsidiary of Merck &
Co., Inc., 1 Merck Dr., P.O. Box 100, Whitehouse
Station, NJ 08889.
B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA
18109.
ANDA 062398 ......................
ANDA 062756 ......................
ANDA 062814 ......................
ANDA 063239 ......................
ANDA 064127 ......................
ANDA 070598 ......................
Amikacin Sulfate in Sodium Chloride 0.9% Injection,
EQ 500 mg base/100 mL.
Metoclopramide HCl Tablets, EQ 10 mg base ...............
ANDA
ANDA
ANDA
ANDA
......................
......................
......................
......................
Furosemide Injection USP, 10 mg/mL ............................
Dipyridamole Injection, 5 mg/mL ....................................
Acyclovir Sodium Injection, EQ 25 mg base/mL ............
Adenosine Injection USP, 3 mg/mL ................................
ANDA 078211 ......................
ANDA 078935 ......................
Quinapril HCl and Hydrochlorothiazide Tablets, EQ 10
mg base/12.5 mg, EQ 20 mg base/12.5 mg, and EQ
20 mg base/25 mg.
Tramadol HCl Tablets USP, 50 mg ................................
ANDA 080810 ......................
Halothane USP, 99.99% .................................................
ANDA 085458 ......................
Dexamethasone Tablets USP, 0.5 mg ...........................
ANDA 085883 ......................
Acetaminophen and Codeine Phosphate Oral Suspension USP, 120 mg/5 mL and 12 mg/5 mL.
ANDA 085884 ......................
Cortisone Acetate Tablets USP, 25 mg ..........................
ANDA 086179 ......................
ANDA 086440 ......................
asabaliauskas on DSKBBXCHB2PROD with NOTICES
ANDA 064146 ......................
Primaxin (cilastatin sodium and imipenem) for Injection,
Equivalent to (EQ) 250 mg base/vial; 250 mg/vial and
EQ 500 mg base/vial; 500 mg/vial.
Gentamicin Sulfate in 0.9% Sodium Chloride Injection,
EQ 0.8 mg base/milliliter (mL), EQ 1.2 mg base/mL,
EQ 1.4 mg base/mL, EQ 1.6 mg base/mL, EQ 1.8
mg base/mL, EQ 2 mg base/mL, EQ 2.4 mg base/
mL, EQ 40 mg base/100 mL, EQ 60 mg base/100
mL, EQ 70 mg base/100 mL, EQ 80 mg base/100
mL, EQ 90 mg base/100 mL, EQ 100 mg base/100
mL, and EQ 120 mg base/100 mL.
Rocephin (ceftriaxone sodium) for Injection USP, EQ
250 mg base/vial, EQ 500 mg base/vial, and EQ 1
gram (g) base/vial.
Erythromycin Topical Solution, 2% .................................
Carisoprodol Tablets USP, 350 mg ................................
Atropine Sulfate and Diphenoxylate HCl Capsules,
0.025 mg/2.5 mg.
Methylprednisolone Sodium Succinate for Injection
USP, EQ 500 mg base/vial and EQ 1 g base/vial.
072080
074601
074720
076564
ANDA 087535 ......................
ANDA 087711 ......................
ANDA 088346 ......................
ANDA 088852 ......................
VerDate Sep<11>2014
17:52 Sep 20, 2017
Dexamethasone Acetate Injectable Suspension USP,
EQ 16 mg base/mL.
Heparin Lock Flush Solution USP and 0.9% Sodium
Chloride Injection USP, 10 USP heparin units/mL and
100 USP heparin units/mL.
Chlorpropamide Tablets USP, 100 mg ...........................
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Hoffmann-La Roche, Inc., c/o Genentech Inc., 1 DNA
Way, MS 241B, South San Francisco, CA 94080.
Renaissance Pharma, Inc., 411 South State St., Suite
E–100, Newton, PA 18940.
Hospira, Inc., Subsidiary of Pfizer Inc., 375 N. Field Dr.,
Lake Forest, IL 60045.
Merck Sharp & Dohme Corp., Subsidiary of Merck &
Co., Inc.
Hospira, Inc., Subsidiary of Pfizer Inc.
Do.
Do.
Teva Pharmaceuticals USA, Inc., 425 Privet Rd.,
Horsham, PA 19044.
Sun Pharmaceutical Industries Ltd., c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way,
Princeton, NJ 08540.
Northstar Healthcare Holdings, c/o Quality Regulatory
Consultants, 1966 Anglers Cove, Vero Beach, FL
32963.
Halocarbon Products Corp., 1100 Dittman Ct., North
Augusta, SC 29841.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA
19044.
Actavis Mid Atlantic LLC, Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA
19044.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Do.
Catalent Pharma Solutions, Inc., 2725 Scherer Dr.
North, St. Petersburg, FL 33716.
Organon USA, Inc., Subsidiary of Merck and Co., Inc.,
126 E. Lincoln Ave., P.O. Box 2000, Rahway, NJ
07065.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Hospira, Inc.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
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Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices
44187
TABLE 1—Continued
Application No.
Drug
Applicant
ANDA 091201 ......................
Meropenem for Injection USP, 500 mg/vial and 1 g/vial
ANDA 200156 ......................
Armodafinil Tablets, 100 mg and 200 mg ......................
Sandoz Inc., 100 College Rd. West, Princeton, NJ
08540.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Therefore, approval of the
applications listed in table 1, and all
amendments and supplements thereto,
is hereby withdrawn, effective October
23, 2017. 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 table 1
that are in inventory on the date that
this notice becomes effective (see the
DATES section) 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: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–20107 Filed 9–20–17; 8:45 a.m.]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5255]
Dermatologic and Ophthalmic Drugs
Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Dermatologic and Ophthalmic Drugs
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to the
Agency on FDA’s regulatory issues. The
meeting will be open to the public. FDA
is establishing a docket for public
comment on this document.
DATES: The public meeting will be held
on October 13, 2017, from 8:30 a.m. to
4 p.m.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:52 Sep 20, 2017
Jkt 241001
FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2017–N–5255.
The docket will close on October 12,
2017. Submit either electronic or
written comments on this public
meeting by October 12, 2017. Late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 12,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of October 12, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Comments received on or before
September 28, 2017, will be provided to
the committee. Comments received after
that date will be taken into
consideration by the Agency.
You may submit comments as
follows:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
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that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–5255 for ‘‘Dermatologic and
Ophthalmic Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
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made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
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with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
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]]>Agencies
[Federal Register Volume 82, Number 182 (Thursday, September 21, 2017)]
[Notices]
[Pages 44185-44187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20107]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5526]
Department of Health and Human Services, Supply Service Center et
al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 27 abbreviated new drug applications (ANDAs) from multiple
applicants. The holders of the applications notified the Agency in
writing that the drug products were no longer marketed and requested
that the approval of the applications be withdrawn.
DATES: Applied Date: October 23, 2017.
[[Page 44186]]
FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945.
SUPPLEMENTARY INFORMATION: The holders of the applications listed in
table 1 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 abbreviated application
under Sec. 314.150(c) is without prejudice to refiling.
Table 1
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 061071................. Tetracycline Department of Health
Hydrochloride (HCl) and Human Services,
Tablets, 250 Supply Service
milligrams (mg). Center, PSC Bldg.
14 Boiler House
Rd., Perry Point,
MD 21902.
ANDA 062279................. Grifulvin V Valeant
(griseofulvin Pharmaceuticals
microsize) Tablets North America, LLC,
USP,125 mg, 250 mg, 400 Somerset
and 500 mg. Corporate Blvd.,
Bridgewater, NJ
08807.
ANDA 062398................. Cephalexin Capsules, Department of Health
250 mg and 500 mg. and Human Services,
Supply Service
Center, PSC Bldg.
14 Boiler House
Rd., Perry Point,
MD 21902.
ANDA 062756................. Primaxin (cilastatin Merck Sharp & Dohme
sodium and Corp., Subsidiary
imipenem) for of Merck & Co.,
Injection, Inc., 1 Merck Dr.,
Equivalent to (EQ) P.O. Box 100,
250 mg base/vial; Whitehouse Station,
250 mg/vial and EQ NJ 08889.
500 mg base/vial;
500 mg/vial.
ANDA 062814................. Gentamicin Sulfate B. Braun Medical
in 0.9% Sodium Inc., 901 Marcon
Chloride Injection, Blvd., Allentown,
EQ 0.8 mg base/ PA 18109.
milliliter (mL), EQ
1.2 mg base/mL, EQ
1.4 mg base/mL, EQ
1.6 mg base/mL, EQ
1.8 mg base/mL, EQ
2 mg base/mL, EQ
2.4 mg base/mL, EQ
40 mg base/100 mL,
EQ 60 mg base/100
mL, EQ 70 mg base/
100 mL, EQ 80 mg
base/100 mL, EQ 90
mg base/100 mL, EQ
100 mg base/100 mL,
and EQ 120 mg base/
100 mL.
ANDA 063239................. Rocephin Hoffmann-La Roche,
(ceftriaxone Inc., c/o Genentech
sodium) for Inc., 1 DNA Way, MS
Injection USP, EQ 241B, South San
250 mg base/vial, Francisco, CA
EQ 500 mg base/ 94080.
vial, and EQ 1 gram
(g) base/vial.
ANDA 064127................. Erythromycin Topical Renaissance Pharma,
Solution, 2%. Inc., 411 South
State St., Suite E-
100, Newton, PA
18940.
ANDA 064146................. Amikacin Sulfate in Hospira, Inc.,
Sodium Chloride Subsidiary of
0.9% Injection, EQ Pfizer Inc., 375 N.
500 mg base/100 mL. Field Dr., Lake
Forest, IL 60045.
ANDA 070598................. Metoclopramide HCl Merck Sharp & Dohme
Tablets, EQ 10 mg Corp., Subsidiary
base. of Merck & Co.,
Inc.
ANDA 072080................. Furosemide Injection Hospira, Inc.,
USP, 10 mg/mL. Subsidiary of
Pfizer Inc.
ANDA 074601................. Dipyridamole Do.
Injection, 5 mg/mL.
ANDA 074720................. Acyclovir Sodium Do.
Injection, EQ 25 mg
base/mL.
ANDA 076564................. Adenosine Injection Teva Pharmaceuticals
USP, 3 mg/mL. USA, Inc., 425
Privet Rd.,
Horsham, PA 19044.
ANDA 078211................. Quinapril HCl and Sun Pharmaceutical
Hydrochlorothiazide Industries Ltd., c/
Tablets, EQ 10 mg o Sun
base/12.5 mg, EQ 20 Pharmaceutical
mg base/12.5 mg, Industries, Inc., 2
and EQ 20 mg base/ Independence Way,
25 mg. Princeton, NJ
08540.
ANDA 078935................. Tramadol HCl Tablets Northstar Healthcare
USP, 50 mg. Holdings, c/o
Quality Regulatory
Consultants, 1966
Anglers Cove, Vero
Beach, FL 32963.
ANDA 080810................. Halothane USP, Halocarbon Products
99.99%. Corp., 1100 Dittman
Ct., North Augusta,
SC 29841.
ANDA 085458................. Dexamethasone Watson Laboratories,
Tablets USP, 0.5 mg. Inc., Subsidiary of
Teva
Pharmaceuticals
USA, Inc., 425
Privet Rd.,
Horsham, PA 19044.
ANDA 085883................. Acetaminophen and Actavis Mid Atlantic
Codeine Phosphate LLC, Subsidiary of
Oral Suspension Teva
USP, 120 mg/5 mL Pharmaceuticals
and 12 mg/5 mL. USA, Inc., 425
Privet Rd.,
Horsham, PA 19044.
ANDA 085884................. Cortisone Acetate Watson Laboratories,
Tablets USP, 25 mg. Inc., Subsidiary of
Teva
Pharmaceuticals
USA, Inc.
ANDA 086179................. Carisoprodol Tablets Do.
USP, 350 mg.
ANDA 086440................. Atropine Sulfate and Catalent Pharma
Diphenoxylate HCl Solutions, Inc.,
Capsules, 0.025 mg/ 2725 Scherer Dr.
2.5 mg. North, St.
Petersburg, FL
33716.
ANDA 087535................. Methylprednisolone Organon USA, Inc.,
Sodium Succinate Subsidiary of Merck
for Injection USP, and Co., Inc., 126
EQ 500 mg base/vial E. Lincoln Ave.,
and EQ 1 g base/ P.O. Box 2000,
vial. Rahway, NJ 07065.
ANDA 087711................. Dexamethasone Watson Laboratories,
Acetate Injectable Inc., Subsidiary of
Suspension USP, EQ Teva
16 mg base/mL. Pharmaceuticals
USA, Inc.
ANDA 088346................. Heparin Lock Flush Hospira, Inc.
Solution USP and
0.9% Sodium
Chloride Injection
USP, 10 USP heparin
units/mL and 100
USP heparin units/
mL.
ANDA 088852................. Chlorpropamide Watson Laboratories,
Tablets USP, 100 mg. Inc., Subsidiary of
Teva
Pharmaceuticals
USA, Inc.
[[Page 44187]]
ANDA 091201................. Meropenem for Sandoz Inc., 100
Injection USP, 500 College Rd. West,
mg/vial and 1 g/ Princeton, NJ
vial. 08540.
ANDA 200156................. Armodafinil Tablets, Watson Laboratories,
100 mg and 200 mg. Inc., Subsidiary of
Teva
Pharmaceuticals
USA, Inc.
------------------------------------------------------------------------
Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn, effective
October 23, 2017. 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 table
1 that are in inventory on the date that this notice becomes effective
(see the DATES section) 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: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20107 Filed 9-20-17; 8:45 a.m.]
BILLING CODE 4164-01-P
