Bayer Healthcare Pharmaceuticals; Withdrawal of Approval of a New Drug Application for BAYCOL (cerivastatin sodium) Tablets, 0.05 Milligrams, 0.1 Milligrams, 0.2 Milligrams, 0.3 Milligrams, 0.4 Milligrams, and 0.8 Milligrams, 39442 [2017-17510]
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39442
Federal Register / Vol. 82, No. 159 / Friday, August 18, 2017 / Notices
Frequency: Annually; Affected Public:
Private Sector: Business or other forprofits and Not-for-profit institutions
and Individuals; Number of
Respondents: 16; Total Annual
Responses: 16; Total Annual Hours:
160. (For policy questions regarding this
collection contact Michelle Peterman at
410–786–2591.)
Dated: August 15, 2017.
Martique Jones,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–17495 Filed 8–17–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4069]
Bayer Healthcare Pharmaceuticals;
Withdrawal of Approval of a New Drug
Application for BAYCOL (cerivastatin
sodium) Tablets, 0.05 Milligrams, 0.1
Milligrams, 0.2 Milligrams, 0.3
Milligrams, 0.4 Milligrams, and 0.8
Milligrams
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of new drug application (NDA)
020740 for BAYCOL (cerivastatin
sodium) tablets, 0.05 milligrams (mg),
0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, and 0.8
mg, held by Bayer Healthcare
Pharmaceuticals (Bayer). Bayer
requested withdrawal of this
application, and has waived its
opportunity for a hearing.
DATES: Approval is withdrawn as of
August 18, 2017.
FOR FURTHER INFORMATION CONTACT:
Kristiana Brugger, Office of Regulatory
Policy, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6262, Silver Spring,
MD 20993, 301–796–3600.
SUPPLEMENTARY INFORMATION: NDA
020740 for BAYCOL (cerivastatin
sodium) tablets, 0.05 mg, 0.1 mg, 0.2
mg, and 0.3 mg, was received on June
26, 1996, under section 505(b) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act). FDA approved NDA 020740
on June 26, 1997, as safe and effective
as an adjunct to diet for the reduction
of elevated total and LDL cholesterol
levels in patients with primary
hypercholesterolemia and mixed
mstockstill on DSK30JT082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:47 Aug 17, 2017
Jkt 241001
dyslipidemia (Frederickson Types IIa
and IIb) when the response to dietary
restriction of saturated fat and
cholesterol and other nonpharmacological measures alone has
been inadequate. Supplemental NDAs
were received by FDA on July 17, 1998,
for the 0.4 mg strength of the drug
(approved on May 24, 1999) and on
September 23, 1999, for the 0.8 mg
strength of the drug (approved on July
21, 2000). The most recently approved
labeling (May 21, 2001) for this drug
stated that: ‘‘BAYCOL® (cerivastatin
sodium tablets) is indicated as an
adjunct to diet to reduce elevated
Total–C, LDL–C, apo B, and TG and to
increase HDL–C levels in patients with
primary hypercholesterolemia and
mixed dyslipidemia (Fredrickson Types
IIa and IIb) when the response to dietary
restriction of saturated fat and
cholesterol and other nonpharmacological measures alone has
been inadequate.’’
Over time, however, reports
associating cerivastatin with
rhabdomyolysis, a potentially fatal
condition involving muscle weakness,
increased. Because of these reports,
Bayer withdrew BAYCOL from the
market on August 8, 2001. On January
24, 2014, Bayer wrote to FDA asking the
Agency to withdraw approval of NDA
020740 under 21 CFR 314.150(d) and
waived its opportunity for a hearing.
Accordingly, under section 505(e) of
the FD&C Act (21 U.S.C. 355(e)) and
section 314.150(d), approval of NDA
020740, and all amendments and
supplements thereto, is withdrawn.
Distribution of BAYCOL (cerivastatin
sodium) tablets, 0.05 mg, 0.1 mg, 0.2
mg, 0.3 mg, 0.4 mg, and 0.8 mg in
interstate commerce without an
approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the FD&C Act (21
U.S.C. 355(a) and 331(d)).
Dated: August 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17510 Filed 8–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Mental Health Council.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Mental Health Council.
Date: September 14, 2017.
Open: 9:00 a.m. to 12:45 p.m.
Agenda: Presentation of the NIMH
Director’s Report and discussion.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Closed: 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Contact Person: Jean G. Noronha, Ph.D.,
Director, Division of Extramural Activities,
National Institute of Mental Health, NIH
Neuroscience Center, 6001 Executive Blvd.,
Room 6154, MSC 9609, Bethesda, MD 20892–
9609, 301–443–3367, jnoronha@mail.nih.gov.
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of organizations may submit
a letter of intent, a brief description of the
organization represented, and a short
description of the oral presentation. Only one
representative of an organization may be
allowed to present oral comments and if
accepted by the committee, presentations
may be limited to five minutes. Both printed
and electronic copies are requested for the
record. In addition, any interested person
may file written comments with the
committee by forwarding their statement to
the Contact Person listed on this notice. The
statement should include the name, address,
telephone number and when applicable, the
business or professional affiliation of the
interested person.
Information is also available on the
Institute’s/Center’s home page:
www.nimh.nih.gov/about/advisory-boardsand-groups/namhc/index.shtml., where an
agenda and any additional information for
the meeting will be posted when available.
E:\FR\FM\18AUN1.SGM
18AUN1
]]>Agencies
[Federal Register Volume 82, Number 159 (Friday, August 18, 2017)]
[Notices]
[Page 39442]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17510]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-4069]
Bayer Healthcare Pharmaceuticals; Withdrawal of Approval of a New
Drug Application for BAYCOL (cerivastatin sodium) Tablets, 0.05
Milligrams, 0.1 Milligrams, 0.2 Milligrams, 0.3 Milligrams, 0.4
Milligrams, and 0.8 Milligrams
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of new drug application (NDA) 020740 for BAYCOL (cerivastatin sodium)
tablets, 0.05 milligrams (mg), 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, and 0.8
mg, held by Bayer Healthcare Pharmaceuticals (Bayer). Bayer requested
withdrawal of this application, and has waived its opportunity for a
hearing.
DATES: Approval is withdrawn as of August 18, 2017.
FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Office of
Regulatory Policy, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6262,
Silver Spring, MD 20993, 301-796-3600.
SUPPLEMENTARY INFORMATION: NDA 020740 for BAYCOL (cerivastatin sodium)
tablets, 0.05 mg, 0.1 mg, 0.2 mg, and 0.3 mg, was received on June 26,
1996, under section 505(b) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act). FDA approved NDA 020740 on June 26, 1997, as safe and
effective as an adjunct to diet for the reduction of elevated total and
LDL cholesterol levels in patients with primary hypercholesterolemia
and mixed dyslipidemia (Frederickson Types IIa and IIb) when the
response to dietary restriction of saturated fat and cholesterol and
other non-pharmacological measures alone has been inadequate.
Supplemental NDAs were received by FDA on July 17, 1998, for the 0.4 mg
strength of the drug (approved on May 24, 1999) and on September 23,
1999, for the 0.8 mg strength of the drug (approved on July 21, 2000).
The most recently approved labeling (May 21, 2001) for this drug stated
that: ``BAYCOL[supreg] (cerivastatin sodium tablets) is indicated as an
adjunct to diet to reduce elevated Total-C, LDL-C, apo B, and TG and to
increase HDL-C levels in patients with primary hypercholesterolemia and
mixed dyslipidemia (Fredrickson Types IIa and IIb) when the response to
dietary restriction of saturated fat and cholesterol and other non-
pharmacological measures alone has been inadequate.''
Over time, however, reports associating cerivastatin with
rhabdomyolysis, a potentially fatal condition involving muscle
weakness, increased. Because of these reports, Bayer withdrew BAYCOL
from the market on August 8, 2001. On January 24, 2014, Bayer wrote to
FDA asking the Agency to withdraw approval of NDA 020740 under 21 CFR
314.150(d) and waived its opportunity for a hearing.
Accordingly, under section 505(e) of the FD&C Act (21 U.S.C.
355(e)) and section 314.150(d), approval of NDA 020740, and all
amendments and supplements thereto, is withdrawn. Distribution of
BAYCOL (cerivastatin sodium) tablets, 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg,
0.4 mg, and 0.8 mg in interstate commerce without an approved
application is illegal and subject to regulatory action (see sections
505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).
Dated: August 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17510 Filed 8-17-17; 8:45 am]
BILLING CODE 4164-01-P
