Morton Grove Pharmaceuticals Inc. et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications; Correction, 27440 [2021-10588]
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Federal Register / Vol. 86, No. 96 / Thursday, May 20, 2021 / Notices
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control No.
21 CFR part or guidance
Topic
807, subpart E ............................................................................
814, subparts A through E ..........................................................
812 ..............................................................................................
‘‘Requests for Feedback on Medical Device Submissions: The
Pre-Submission Program and Meetings with Food and Drug
Administration Staff’’.
50, 56 ..........................................................................................
Premarket notification ................................................................
Premarket approval ....................................................................
Investigational Device Exemption ..............................................
Q-submissions ...........................................................................
0910–0120
0910–0231
0910–0078
0910–0756
Protection of Human Subjects: Informed Consent; Institutional
Review Boards.
Institutional Review Boards .......................................................
0910–0755
56 ................................................................................................
Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–10599 Filed 5–19–21; 8:45 am]
BILLING CODE 4164–01–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;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of March 5, 2021. The
document announced the withdrawal of
approval of seven abbreviated new drug
applications (ANDAs) from multiple
applicants as of April 5, 2021. The
document indicated that FDA was
withdrawing approval of the following
five ANDAs, after receiving a
withdrawal request from Neopharma,
Inc., 211 College Road East, Suite 101,
Princeton, NJ 08540: ANDA 078383,
Pioglitazone Hydrochloride (HCl)
Tablets, Equivalent to (EQ) 15
milligrams (mg) base, EQ 30 mg base,
and EQ 45 mg base; ANDA 078953,
Irinotecan HCl Injection, 40 mg/2
milliliters (mL) (20 mg/mL) and 100 mg/
5 mL (20 mg/mL); ANDA 079049,
Alendronate Sodium Tablets, EQ 5 mg
base, EQ 10 mg base, EQ 35 mg base,
and EQ 70 mg base; ANDA 090732,
Anastrozole Tablets, 1 mg; and ANDA
203161, Irbesartan Tablets, 75 mg, 150
mg, and 300 mg. Before FDA withdrew
the approval of these ANDAs,
Neopharma, Inc., informed FDA that it
did not want the approval of the ANDAs
withdrawn. Because Neopharma, Inc.,
timely requested that approval of these
ANDAs not be withdrawn, the approval
SUMMARY:
VerDate Sep<11>2014
17:36 May 19, 2021
Jkt 253001
of ANDAs 078383, 078953, 079049,
090732, and 203161 is still in effect.
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: In the
Federal Register of Friday, March 5,
2021 (86 FR 12950), appearing on page
12950 in FR Doc. 2021–04520, the
following corrections are made on pages
12950 and 12951 in the table:
The entries for ANDAs 078383,
078953, 079049, 090732, and 203161 are
removed.
Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–10588 Filed 5–19–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–P–0162]
Determination That NORMODYNE
(Labetalol Hydrochloride) Injection, 5
Milligrams per Milliliter, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that NORMODYNE
(labetalol hydrochloride) injection, 5
milligrams per milliliter (mg/mL), 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
SUMMARY:
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
0910–0130
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Christopher Koepke, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–3600,
Christopher.Koepke@fda.hhs.gov.
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 (§ 314.161 (21 CFR 314.161)).
E:\FR\FM\20MYN1.SGM
20MYN1
]]>Agencies
[Federal Register Volume 86, Number 96 (Thursday, May 20, 2021)]
[Notices]
[Page 27440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10588]
-----------------------------------------------------------------------
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; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of March 5, 2021. The document
announced the withdrawal of approval of seven abbreviated new drug
applications (ANDAs) from multiple applicants as of April 5, 2021. The
document indicated that FDA was withdrawing approval of the following
five ANDAs, after receiving a withdrawal request from Neopharma, Inc.,
211 College Road East, Suite 101, Princeton, NJ 08540: ANDA 078383,
Pioglitazone Hydrochloride (HCl) Tablets, Equivalent to (EQ) 15
milligrams (mg) base, EQ 30 mg base, and EQ 45 mg base; ANDA 078953,
Irinotecan HCl Injection, 40 mg/2 milliliters (mL) (20 mg/mL) and 100
mg/5 mL (20 mg/mL); ANDA 079049, Alendronate Sodium Tablets, EQ 5 mg
base, EQ 10 mg base, EQ 35 mg base, and EQ 70 mg base; ANDA 090732,
Anastrozole Tablets, 1 mg; and ANDA 203161, Irbesartan Tablets, 75 mg,
150 mg, and 300 mg. Before FDA withdrew the approval of these ANDAs,
Neopharma, Inc., informed FDA that it did not want the approval of the
ANDAs withdrawn. Because Neopharma, Inc., timely requested that
approval of these ANDAs not be withdrawn, the approval of ANDAs 078383,
078953, 079049, 090732, and 203161 is still in effect.
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: In the Federal Register of Friday, March 5,
2021 (86 FR 12950), appearing on page 12950 in FR Doc. 2021-04520, the
following corrections are made on pages 12950 and 12951 in the table:
The entries for ANDAs 078383, 078953, 079049, 090732, and 203161
are removed.
Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10588 Filed 5-19-21; 8:45 am]
BILLING CODE 4164-01-P
