Allergan Pharmaceuticals International, LTD; Withdrawal of Approval of a New Drug Application for LO MINASTRIN FE, 57450 [2019-23309]
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Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices
annually, and assume each notification
requires 16 hours to prepare and submit.
Finally, the guidance recommends
developing a Plan for each individual
manufacturing facility as well as a
broader Plan that addresses multiple
sites within the organization. For
purposes of this information collection
analysis, we consider the Plan for an
individual manufacturing facility and
the broader Plan to comprise one Plan
for each manufacturer. Based on
available data on the number of
manufacturers that would be covered by
the guidance, we previously estimated
70 manufacturers will develop a Plan as
recommended by the guidance (i.e., one
Plan per manufacturer, to include all
manufacturing facilities, sites, and drug
products) and that each Plan would take
approximately 500 hours to develop.
Upon development of the plan,
however, we believe fewer hours are
necessary to maintain and update it as
needed. As FDA issued the guidance in
2011, we now assume that most
respondents have developed the
recommended plan, and therefore we
limit our current burden estimate to
updates and maintenance. Accordingly,
we have reduced our estimate by half,
reasoning that, although it takes fewer
hours for updates and maintenance,
new respondents may choose to adopt
recommendations found in the
guidance.
Dated: October 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–23272 Filed 10–24–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–4310]
Allergan Pharmaceuticals
International, LTD; Withdrawal of
Approval of a New Drug Application for
LO MINASTRIN FE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
withdrawing approval of a new drug
application (NDA) for LO MINASTRIN
FE (ethinyl estradiol tablets, 0.01
milligrams (mg); ethinyl estradiol and
norethindrone acetate tablets, 0.01 mg/
1mg; and ferrous fumarate tablets, 75
mg), held by Allergan Pharmaceuticals
International, LTD, c/o Allergan Sales,
LLC, 5 Giralda Farms, Madison, NJ
07940 (Allergan). Allergan notified the
Agency in writing that the drug product
was no longer marketed and requested
that the approval of the application be
withdrawn.
Approval is withdrawn as of
November 25, 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.
Allergan
has informed FDA that LO MINASTRIN
FE (ethinyl estradiol tablets, 0.01 mg;
ethinyl estradiol and norethindrone
acetate tablets, 0.01 mg/1 mg; and
ferrous fumarate tablets, 75 mg) is no
longer marketed and has requested that
FDA withdraw approval of NDA 204654
under the process in § 314.150(c) (21
CFR 314.150(c)). Allergan has also, by
its request, waived its opportunity for a
hearing. Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
Therefore, approval of NDA 204654,
and all amendments and supplements
thereto, is hereby withdrawn as of
November 25, 2019. Approval of the
entire application is withdrawn,
including any strengths and dosage
forms inadvertently missing from this
notice. Introduction or delivery for
introduction into interstate commerce of
a product without an approved new
drug application violates section 301(a)
and (d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Any Lo Minastrin Fe that is in inventory
on November 25, 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.
SUPPLEMENTARY INFORMATION:
Dated: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–23309 Filed 10–24–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–N–3163; FDA–
2012–D–0429; FDA–2012–D–0049; FDA–
2018–N–3031; FDA–2011–D–0125; FDA–
2018–N–4428; FDA–2012–N–0560; FDA–
2010–N–0414; FDA–2012–N–1203; and
FDA–2019–N–0430]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
publishing a list of information
collections that have been approved by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA).
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
Title of collection
Physician Interpretation of Information About Prescription Drugs in Scientific Publications Versus Promotional
Pieces ...................................................................................................................................................................
Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products .......................................................................................................................................................................
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8/31/2022
]]>Agencies
[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Page 57450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23309]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-4310]
Allergan Pharmaceuticals International, LTD; Withdrawal of
Approval of a New Drug Application for LO MINASTRIN FE
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of a new drug application (NDA) for LO MINASTRIN
FE (ethinyl estradiol tablets, 0.01 milligrams (mg); ethinyl estradiol
and norethindrone acetate tablets, 0.01 mg/1mg; and ferrous fumarate
tablets, 75 mg), held by Allergan Pharmaceuticals International, LTD,
c/o Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ 07940 (Allergan).
Allergan notified the Agency in writing that the drug product was no
longer marketed and requested that the approval of the application be
withdrawn.
DATES: Approval is withdrawn as of November 25, 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: Allergan has informed FDA that LO MINASTRIN
FE (ethinyl estradiol tablets, 0.01 mg; ethinyl estradiol and
norethindrone acetate tablets, 0.01 mg/1 mg; and ferrous fumarate
tablets, 75 mg) is no longer marketed and has requested that FDA
withdraw approval of NDA 204654 under the process in Sec. 314.150(c)
(21 CFR 314.150(c)). Allergan has also, by its request, waived its
opportunity for a hearing. Withdrawal of approval of an application or
abbreviated application under Sec. 314.150(c) is without prejudice to
refiling.
Therefore, approval of NDA 204654, and all amendments and
supplements thereto, is hereby withdrawn as of November 25, 2019.
Approval of the entire application is withdrawn, including any
strengths and dosage forms inadvertently missing from this notice.
Introduction or delivery for introduction into interstate commerce of a
product without an approved new drug application violates section
301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
331(a) and (d)). Any Lo Minastrin Fe that is in inventory on November
25, 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: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23309 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P
