Roerig Division of Pfizer Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications; Correction, 61004 [2020-21456]
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Federal Register / Vol. 85, No. 189 / Tuesday, September 29, 2020 / Notices
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Dated: September 18, 2020.
Lauren K. Roth,
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SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of Tuesday,
July 21, 2020 (85 FR 44096), appearing
on page 44096 in FR Doc. 2020–15727,
the following correction is made:
On page 44096, in the table, the
entries for ANDAs 076203 and 077456
are removed.
Dated: September 21, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–21456 Filed 9–28–20; 8:45 am]
BILLING CODE 4164–01–P
[FR Doc. 2020–21465 Filed 9–28–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1227]
Roerig Division of Pfizer Inc., et al.;
Withdrawal of Approval of 10
Abbreviated New Drug Applications;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
[Docket No. FDA–2013–D–1445]
Blood Glucose Monitoring Test
Systems for Prescription Point-of-Care
Use; Guidance for Industry and Food
and Drug Administration Staff;
Availability
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Blood Glucose
Monitoring Test Systems for
Prescription Point-of-Care Use.’’ This
guidance describes studies and
information that FDA recommends be
used when submitting premarket
notifications (510(k)s) for blood glucose
monitoring systems (BGMSs) that are for
prescription point-of-care use.
DATES: The announcement of the
guidance is published in the Federal
Register on September 29, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on July 21, 2020. The
document announced the withdrawal of
approval of 10 abbreviated new drug
applications (ANDAs) from multiple
applicants, withdrawn as of August 20,
2020. The document indicated that FDA
was withdrawing approval of the
following two ANDAs after receiving a
withdrawal request from Kadmon
Pharmaceuticals, LLC., 119
Commonwealth Dr., Warrendale, PA
15086: ANDA 076203, Ribavirin
Capsules, 200 milligrams (mg) and
ANDA 077456, Ribavirin Tablets, 200
mg, 400 mg, and 600 mg. Before FDA
withdrew the approval of these ANDAs,
Kadmon Pharmaceuticals, LLC.
informed FDA that it did not want the
approval of the ANDAs withdrawn.
Because Kadmon Pharmaceuticals,
LLC., timely requested that approval of
these ANDAs not be withdrawn, the
approval of ANDAs 076203 and 077456
are still in effect.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
SUMMARY:
Food and Drug Administration
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
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]]>Agencies
[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Page 61004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21456]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1227]
Roerig Division of Pfizer Inc., et al.; Withdrawal of Approval of
10 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 on July 21, 2020. The document
announced the withdrawal of approval of 10 abbreviated new drug
applications (ANDAs) from multiple applicants, withdrawn as of August
20, 2020. The document indicated that FDA was withdrawing approval of
the following two ANDAs after receiving a withdrawal request from
Kadmon Pharmaceuticals, LLC., 119 Commonwealth Dr., Warrendale, PA
15086: ANDA 076203, Ribavirin Capsules, 200 milligrams (mg) and ANDA
077456, Ribavirin Tablets, 200 mg, 400 mg, and 600 mg. Before FDA
withdrew the approval of these ANDAs, Kadmon Pharmaceuticals, LLC.
informed FDA that it did not want the approval of the ANDAs withdrawn.
Because Kadmon Pharmaceuticals, LLC., timely requested that approval of
these ANDAs not be withdrawn, the approval of ANDAs 076203 and 077456
are 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:
Correction
In the Federal Register of Tuesday, July 21, 2020 (85 FR 44096),
appearing on page 44096 in FR Doc. 2020-15727, the following correction
is made:
On page 44096, in the table, the entries for ANDAs 076203 and
077456 are removed.
Dated: September 21, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21456 Filed 9-28-20; 8:45 am]
BILLING CODE 4164-01-P
