[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]


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DATES: Approval is withdrawn as of August 18, 2017.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