82 FR 39442 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 159 (August 18, 2017)

Page Range		39442-39442
FR Document		2017-17510

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.

Federal Register, Volume 82 Issue 159 (Friday, August 18, 2017)

[Federal Register Volume 82, Number 159 (Friday, August 18, 2017)]
[Notices]
[Page 39442]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-17510]


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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.

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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DATES: Approval is withdrawn as of August 18, 2017.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

39442 Federal Register / Vol. 82, No. 159 / Friday, August 18, 2017 / Notices

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

National Institute of Mental Health; business or professional affiliation of the
Federal Food, Drug, and Cosmetic Act
Notice of Meeting interested person.
(FD&C Act). FDA approved NDA 020740 Information is also available on the
on June 26, 1997, as safe and effective Pursuant to section 10(d) of the Institute’s/Center’s home page:
as an adjunct to diet for the reduction Federal Advisory Committee Act, as www.nimh.nih.gov/about/advisory-boards-
of elevated total and LDL cholesterol amended, notice is hereby given of a and-groups/namhc/index.shtml., where an
levels in patients with primary meeting of the National Advisory agenda and any additional information for
hypercholesterolemia and mixed Mental Health Council. the meeting will be posted when available.

VerDate Sep<11>2014 17:47 Aug 17, 2017 Jkt 241001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\18AUN1.SGM 18AUN1

Document Created: 2017-08-18 07:40:40
Document Modified: 2017-08-18 07:40:40

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Approval is withdrawn as of August 18, 2017.
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.
FR Citation		82 FR 39442

82 FR 39442 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 159 (August 18, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration