Teva Women's Health, Inc., et al.; Withdrawal of Approval of 16 New Drug Applications, 12262-12263 [2019-06237]
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Federal Register / Vol. 84, No. 62 / Monday, April 1, 2019 / Notices
• Section 485.705(c)(2) through (c)(6),
to ensure AAAASF’s standards
appropriately reference the CMS
standards;
• Section 485.719(b)(3), to ensure
AAAASF’s standards appropriately
reference the statutory requirements;
• Section 488.5(a)(4)(ii), to ensure
that an appropriate number of medical
records are fully reviewed during the
survey process and that survey record
totals are accurately reflected in the
overall deficiency statement;
• Section 488.5(a)(4)(iv), to ensure all
deficiencies found on survey are cited
in AAAASF’s final survey report;
• Section 488.5(a)(4)(vii), to ensure
appropriate monitoring of noncompliance correction;
• Section 488.5(a)(11)(ii), to ensure
accurate survey findings are reported to
CMS;
• Section 488.5(a)(13)(ii), to ensure
AAAASF notifies CMS regarding any
decision to revoke, withdraw, or revise
the accreditation status of a deemed
status supplier;
• Section 488.26(b) and (c), to ensure
deficiencies are cited at the appropriate
level based on manner and degree of
findings;
• Section 488.28(a), to ensure
AAAASF’s policies for an acceptable
plan of correction meet the CMS
requirements;
• Section 488.28(d), to ensure that
AAAASF’s policies for correction of
deficiencies in OPTs is comparable to
CMS requirements, requiring that
deficiencies normally must be corrected
within 60 days; and
• Section 489.13(b)(1), to ensure all
enrollment requirements are met prior
to AAAASF surveying an initial
applicant.
B. Term of Approval
Based on our review and observations
described in section III of this final
notice, we approve AAAASF as a
national accreditation organization for
OPTs that request participation in the
Medicare program, effective April 4,
2019 through April 4, 2025.
V. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or third
party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35).
VerDate Sep<11>2014
17:22 Mar 29, 2019
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Dated: March 15, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2019–06149 Filed 3–29–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0895]
Issuance of Priority Review Voucher;
Material Threat Medical
Countermeasure Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Act, go to https://www.fda.gov/
EmergencyPreparedness/
Counterterrorism/MedicalCounter
measures/MCMLegalRegulatoryand
PolicyFramework/ucm566498.htm#prv.
For further information about TPOXX
(tecovirimat), go to the ‘‘Drugs@FDA’’
website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: March 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06145 Filed 3–29–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a material threat medical
countermeasure (MCM) product
application. The Federal Food, Drug,
and Cosmetic Act (FD&C Act), as
amended by the 21st Century Cures Act
(Cures Act), authorizes FDA to award
priority review vouchers to sponsors of
approved material threat MCM product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
On July 13, 2018, FDA determined that
TPOXX (tecovirimat), manufactured by
SIGA Technologies, Inc., meets the
criteria for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Sadove, Office of
Counterterrorism and Emerging Threats,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–796–8510.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved material threat MCM product
application. Under section 565A of the
FD&C Act (21 U.S.C. 360bbb-4a), which
was added by the Cures Act, FDA will
award priority review vouchers to
sponsors of approved material threat
MCM product applications that meet
certain criteria. FDA has determined
that TPOXX (tecovirimat), manufactured
by SIGA Technologies, Inc., meets the
criteria for a priority review voucher.
TPOXX (tecovirimat) is indicated to
treat human smallpox disease in adults
and pediatric patients weighing at least
13 kilograms.
For further information about the
material threat MCM Priority Review
Voucher Program and for a link to the
full text of section 565A of the FD&C
Food and Drug Administration
SUMMARY:
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[Docket No. FDA–2019–N–0598]
Teva Women’s Health, Inc., et al.;
Withdrawal of Approval of 16 New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 16 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.
SUMMARY:
Approval is withdrawn as of
May 1, 2019.
DATES:
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.
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.
SUPPLEMENTARY INFORMATION:
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01APN1
Federal Register / Vol. 84, No. 62 / Monday, April 1, 2019 / Notices
Application No.
Drug
NDA 007883 ............
Antabuse (disulfiram) Tablets, 250 milligrams (mg) and 500
mg.
Sinografin (diatrizoate meglumine and iodipadmide
meglumine) Injection, 52.7%/26.8%.
ReVia (naltrexone hydrochloride) Tablets, 50 mg ................
Paraplatin (carboplatin) Injection, 50 mg/vial, 150 mg/vial,
and 450 mg/vial.
Lescol (fluvastatin sodium) Capsules, 20 mg and 40 mg .....
NDA 011324 ............
NDA 018932 ............
NDA 019880 ............
NDA 020261 ............
NDA 020452 ............
Applicant
NDA 021905 ............
Paraplatin (carboplatin) Injection in multiple dose vials, 50
mg/5 milliliters (mL), 150 mg/15 mL, 450 mg/45 mL, and
600 mg/60 mL.
Campral (acamprosate calcium) Delayed-Release Tablets,
333 mg.
Halflytely and Bisacodyl Tablet Bowel Prep Kit (polyethylene glycol 3350, potassium chloride, sodium bicarbonate, and sodium chloride powder for oral solution,
210 grams (g)/0.74 g/2.86 g/5.6 g; bisacodyl delayed-release tablet, 5 mg).
Actonel with Calcium (risedronate sodium tablets, 35 mg;
calcium carbonate tablets USP, equivalent to 500 mg
base).
Valtropine (somatropin) for Injection, 5 mg/vial ....................
NDA 022396 ............
Dyloject (diclofenac sodium) Injection, 37.5 mg/mL .............
NDA 050619 ............
Mycostatin (nystatin) Pastilles, 200,000 Units ......................
NDA 050739 ............
Omnicef (cefdinir) Capsules, 300 mg ....................................
NDA 050749 ............
Omnicef (cefdinir) Oral Suspension, 125 mg/5 mL and 250
mg/5 mL.
PrevPAC (amoxicillin capsules USP, 500 mg;
clarithromycin tablets USP, 500 mg; and lansoprazole
delayed-release capsules, 30 mg).
Docetaxel Injection, 20 mg/2 mL, 80 mg/8 mL, 130 mg/13
mL, and 200 mg/20 mL.
NDA 021431 ............
NDA 021551 ............
NDA 021823 ............
NDA 050757 ............
NDA 202356 ............
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of May 1, 2019.
The drug product strengths listed in the
table include all strengths FDA has
identified as being previously approved
under these NDAs. In each case,
approval of the entire application is
withdrawn, including any strengths
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 May 1, 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: March 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06237 Filed 3–29–19; 8:45 am]
BILLING CODE 4164–01–P
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Jkt 247001
Teva Women’s Health, Inc., 41 Moores Rd., P.O. Box
4011, Frazer, PA 19355.
Bracco Diagnostic Inc., 259 Prospect Plains Rd., Bldg. H,
Monroe Township, NJ 08831.
Teva Women’s Health, Inc.
Corden Pharma Latina S.p.A., c/o Clinipace, Inc., 4840
Pearl East Circle, Suite 201E, Boulder, CO 80301.
Novartis Pharmaceuticals Corp., One Health Plaza, East
Hanover, NJ 07936–1080.
Corden Pharma Latina S.p.A.
Allergan Sales, LLC., 5 Giralda Farms, Madison, NJ 07940.
Braintree Laboratories, Inc., 60 Columbian St. West, P.O.
Box 850929, Braintree, MA 02185.
Warner Chilcott Co., LLC., 100 Enterprise Dr., Rockaway,
NJ 07866.
LG Chem, Ltd., c/o Parexel International, LLC., 4600 EastWest Highway, Suite 350, Bethesda, MD 20814.
Javelin Pharmaceuticals, Inc., c/o Hospira, Inc., 275 North
Field Dr., Dept. 0389, HI–3S, Lake Forest, IL 60045.
Delcor Asset Corp., c/o Mylan, Inc., 781 Chestnut Ridge
Rd., P.O. Box 4310, Morgantown, WV 26504–4310.
AbbVie Inc., 1 North Waukegan Rd., North Chicago, IL
60064.
Do.
Takeda Pharmaceuticals U.S.A., Inc., One Takeda Parkway, Deerfield, IL 60015.
Pfizer Inc., 235 East 42nd St., New York, NY 10017.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Charter Renewal for the Advisory
Committee on Interdiciplinary,
Community-Based Linkages
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
ACTION:
Notice.
The Advisory Committee on
Interdiciplinary, Community-Based
Linkages (ACICBL or the Committee)
has been rechartered. The effective date
of the renewed charter is March 24,
2019.
SUMMARY:
Joan
Weis, Ph.D., RN, CRNP, FAAN,
Designated Federal Official, at 301–443–
0430 or email at jweiss@hrsa.gov. A
copy of the current committee
membership, charter, and reports can be
obtained at https://www.hrsa.gov/
advisory-committees/interdisciplinarycommunity-linkages/.
FOR FURTHER INFORMATION CONTACT:
PO 00000
12263
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ACICBL
provides advice and recommendations
on policy and program development to
the Secretary of HHS (Secretary)
concerning the activities under Title VII,
Part D of the Public Health Service Act,
and is responsible for submitting an
annual report to the Secretary and
Congress describing the activities of the
Committee, including findings and
recommendations made by the
Committee concerning the activities
under Part D of Title VII. ACICBL
develops, publishes, and implements
performance measures and guidelines
for longitudinal evaluations and
recommends appropriation levels for
programs under this part. The charter
renewal for the ACICBL was approved
on March 15, 2019 and the filing date
is March 24, 2019. Renewal of the
ACICBL charter gives authorization for
the Committee to operate until March
24, 2021.
A copy of the ACICBL charter is
available on the committee website at
https://www.hrsa.gov/advisorycommittees/interdisciplinarycommunity-linkages/. A copy
of the charter can also be obtained by
SUPPLEMENTARY INFORMATION:
E:\FR\FM\01APN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Notices]
[Pages 12262-12263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06237]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0598]
Teva Women's Health, Inc., et al.; Withdrawal of Approval of 16
New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 16 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 May 1, 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.
[[Page 12263]]
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 007883................ Antabuse (disulfiram) Teva Women's Health,
Tablets, 250 Inc., 41 Moores Rd.,
milligrams (mg) and P.O. Box 4011,
500 mg. Frazer, PA 19355.
NDA 011324................ Sinografin Bracco Diagnostic
(diatrizoate Inc., 259 Prospect
meglumine and Plains Rd., Bldg. H,
iodipadmide Monroe Township, NJ
meglumine) 08831.
Injection, 52.7%/
26.8%.
NDA 018932................ ReVia (naltrexone Teva Women's Health,
hydrochloride) Inc.
Tablets, 50 mg.
NDA 019880................ Paraplatin Corden Pharma Latina
(carboplatin) S.p.A., c/o
Injection, 50 mg/ Clinipace, Inc.,
vial, 150 mg/vial, 4840 Pearl East
and 450 mg/vial. Circle, Suite 201E,
Boulder, CO 80301.
NDA 020261................ Lescol (fluvastatin Novartis
sodium) Capsules, 20 Pharmaceuticals
mg and 40 mg. Corp., One Health
Plaza, East Hanover,
NJ 07936-1080.
NDA 020452................ Paraplatin Corden Pharma Latina
(carboplatin) S.p.A.
Injection in
multiple dose vials,
50 mg/5 milliliters
(mL), 150 mg/15 mL,
450 mg/45 mL, and
600 mg/60 mL.
NDA 021431................ Campral (acamprosate Allergan Sales, LLC.,
calcium) Delayed- 5 Giralda Farms,
Release Tablets, 333 Madison, NJ 07940.
mg.
NDA 021551................ Halflytely and Braintree
Bisacodyl Tablet Laboratories, Inc.,
Bowel Prep Kit 60 Columbian St.
(polyethylene glycol West, P.O. Box
3350, potassium 850929, Braintree,
chloride, sodium MA 02185.
bicarbonate, and
sodium chloride
powder for oral
solution, 210 grams
(g)/0.74 g/2.86 g/
5.6 g; bisacodyl
delayed-release
tablet, 5 mg).
NDA 021823................ Actonel with Calcium Warner Chilcott Co.,
(risedronate sodium LLC., 100 Enterprise
tablets, 35 mg; Dr., Rockaway, NJ
calcium carbonate 07866.
tablets USP,
equivalent to 500 mg
base).
NDA 021905................ Valtropine LG Chem, Ltd., c/o
(somatropin) for Parexel
Injection, 5 mg/vial. International, LLC.,
4600 East-West
Highway, Suite 350,
Bethesda, MD 20814.
NDA 022396................ Dyloject (diclofenac Javelin
sodium) Injection, Pharmaceuticals,
37.5 mg/mL. Inc., c/o Hospira,
Inc., 275 North
Field Dr., Dept.
0389, HI-3S, Lake
Forest, IL 60045.
NDA 050619................ Mycostatin (nystatin) Delcor Asset Corp., c/
Pastilles, 200,000 o Mylan, Inc., 781
Units. Chestnut Ridge Rd.,
P.O. Box 4310,
Morgantown, WV 26504-
4310.
NDA 050739................ Omnicef (cefdinir) AbbVie Inc., 1 North
Capsules, 300 mg. Waukegan Rd., North
Chicago, IL 60064.
NDA 050749................ Omnicef (cefdinir) Do.
Oral Suspension, 125
mg/5 mL and 250 mg/5
mL.
NDA 050757................ PrevPAC (amoxicillin Takeda
capsules USP, 500 Pharmaceuticals
mg; clarithromycin U.S.A., Inc., One
tablets USP, 500 mg; Takeda Parkway,
and lansoprazole Deerfield, IL 60015.
delayed-release
capsules, 30 mg).
NDA 202356................ Docetaxel Injection, Pfizer Inc., 235 East
20 mg/2 mL, 80 mg/8 42nd St., New York,
mL, 130 mg/13 mL, NY 10017.
and 200 mg/20 mL.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of May
1, 2019. The drug product strengths listed in the table include all
strengths FDA has identified as being previously approved under these
NDAs. In each case, approval of the entire application is withdrawn,
including any strengths 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 May 1, 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: March 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06237 Filed 3-29-19; 8:45 am]
BILLING CODE 4164-01-P
