Morton Grove Pharmaceuticals Inc. et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications, 12950-12951 [2021-04520]
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Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Notices
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[FR Doc. 2021–04515 Filed 3–4–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0033]
Morton Grove Pharmaceuticals Inc. et
al.; Withdrawal of Approval of Seven
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of seven
abbreviated new drug applications
(ANDAs) 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withdrawn.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Approval is withdrawn as of
April 5, 2021.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
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
described 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.
DATES:
Application No.
Drug
Applicant
ANDA 065428 ........
Cefprozil Tablets, 250 milligrams (mg) and 500 mg .............
ANDA 077699 ........
Mefloquine Hydrochloride (HCl) Tablets, 250 mg .................
ANDA 078383 ........
Pioglitazone HCl Tablets, Equivalent to (EQ) 15 mg base;
EQ 30 mg base; EQ 45 mg base.
Irinotecan HCl Injection, 40 mg/2 milliliters (mL) (20 mg/mL)
and 100 mg/5 mL (20 mg/mL).
Alendronate Sodium Tablets, EQ 5 mg base; EQ 10 mg
base; EQ 35 mg base; EQ 70 mg base.
Morton Grove Pharmaceuticals Inc./Wockhardt USA LLC.,
6451 Main St., Morton Grove, IL 60053.
Hikma Pharmaceuticals USA Inc., 1809 Wilson Rd., Columbus, OH 43228.
Neopharma Inc., 211 College Road East, Suite 101, Princeton, NJ 08540.
Do.
ANDA 078953 ........
ANDA 079049 ........
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Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Notices
Application No.
Drug
ANDA 090732 ........
ANDA 203161 ........
Anastrozole Tablets, 1 mg .....................................................
Irbesartan Tablets, 75 mg, 150 mg, and 300 mg ..................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of April 5, 2021.
Approval of each entire application is
withdrawn, including any strengths and
dosage forms 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 April 5, 2021 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: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04520 Filed 3–4–21; 8:45 am]
BILLING CODE 4164–01–P
Do.
Do.
Consortium (CDISC) Study Data
Tabulation Model (SDTM) and the dates
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begin on March 15, 2022.
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ADDRESSES:
Food and Drug Administration
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[Docket No. FDA–2020–N–2354]
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AGENCY:
ACTION:
Food and Drug Administration,
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Drug Evaluation and Research
(CDER) is announcing the date that
support will begin for version 1.1 of the
Clinical Data Interchange Standards
Consortium (CDISC) Standard for
Exchange of Nonclinical Data
Developmental and Reproductive
Toxicology Implementation Guide
(SENDIG–DART) and version 1.6 of the
Clinical Data Interchange Standards
SUMMARY:
VerDate Sep<11>2014
20:30 Mar 04, 2021
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You may submit comments
as follows.
HHS.
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Applicant
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Data Standards; Requirement Begins
for the Clinical Data Interchange
Standards Consortium Version 1.1 of
the Standard for Exchange of
Nonclinical Data Developmental and
Reproductive Toxicology
Implementation Guide and Version 1.6
of the Study Data Tabulation Model;
Clarification to Food and Drug
Administration Data Standards
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]]>Agencies
[Federal Register Volume 86, Number 42 (Friday, March 5, 2021)]
[Notices]
[Pages 12950-12951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04520]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0033]
Morton Grove Pharmaceuticals Inc. et al.; Withdrawal of Approval
of Seven Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of seven abbreviated new drug applications (ANDAs)
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 April 5, 2021.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].
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 described 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
------------------------------------------------------------------------
ANDA 065428.................. Cefprozil Tablets, Morton Grove
250 milligrams (mg) Pharmaceuticals
and 500 mg. Inc./Wockhardt USA
LLC., 6451 Main
St., Morton Grove,
IL 60053.
ANDA 077699.................. Mefloquine Hikma
Hydrochloride (HCl) Pharmaceuticals
Tablets, 250 mg. USA Inc., 1809
Wilson Rd.,
Columbus, OH
43228.
ANDA 078383.................. Pioglitazone HCl Neopharma Inc., 211
Tablets, Equivalent College Road East,
to (EQ) 15 mg base; Suite 101,
EQ 30 mg base; EQ Princeton, NJ
45 mg base. 08540.
ANDA 078953.................. Irinotecan HCl Do.
Injection, 40 mg/2
milliliters (mL)
(20 mg/mL) and 100
mg/5 mL (20 mg/mL).
ANDA 079049.................. Alendronate Sodium Do.
Tablets, EQ 5 mg
base; EQ 10 mg
base; EQ 35 mg
base; EQ 70 mg base.
[[Page 12951]]
ANDA 090732.................. Anastrozole Tablets, Do.
1 mg.
ANDA 203161.................. Irbesartan Tablets, Do.
75 mg, 150 mg, and
300 mg.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of April
5, 2021. Approval of each entire application is withdrawn, including
any strengths and dosage forms 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 April 5, 2021 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: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04520 Filed 3-4-21; 8:45 am]
BILLING CODE 4164-01-P
