[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3435-3436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01096]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-P-3319]
Determination That MEVACOR (Lovastatin) Tablets, 20 Milligrams
and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety
or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that MEVACOR (lovastatin) tablets, 20 milligrams (mg) and 40
mg, were not withdrawn from sale for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to these drug products, and it will allow FDA to
continue to approve ANDAs that refer to the products as long as they
meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Kate Greenwood, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire
[[Page 3436]]
Ave., Bldg. 51, Rm. 6286, Silver Spring, MD 20993-0002, 240-402-1748.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
MEVACOR (lovastatin) tablets, 20 mg and 40 mg, are the subject of
NDA 19-643, held by Merck & Co. Inc., and initially approved on August
31, 1987. MEVACOR is indicated: (1) To reduce the risk of myocardial
infarction, unstable angina, and coronary revascularization procedures
in individuals without symptomatic cardiovascular disease, average to
moderately elevated total cholesterol (total-C) and low-density
lipoprotein cholesterol (LDL-C), and below average high-density
lipoprotein cholesterol; (2) to slow the progression of coronary
atherosclerosis in patients with coronary heart disease as part of a
treatment strategy to lower total-C and LDL-C to target levels; and (3)
as an adjunct to diet for the reduction of elevated total-C and LDL-C
levels in patients with primary hypercholesterolemia (Types IIa and
IIb), when the response to diet restricted in saturated fat and
cholesterol and to other nonpharmacological measures alone has been
inadequate. MEVACOR is also indicated as an adjunct to diet to reduce
total-C, LDL-C, and apolipoprotein B levels in adolescent boys and
girls who are at least 1 year post-menarche, 10-17 years of age, with
heterozygous familial hypercholesterolemia if, after an adequate trial
of diet therapy, the following findings are present: (1) LDL-C remains
>189 mg/deciliter (dL) or (2) LDL-C remains >160 mg/dL and there is a
positive family history of premature cardiovascular disease (CVD) or
two or more other CVD risk factors are present in the adolescent
patient.
MEVACOR (lovastatin) tablets, 20 mg and 40 mg, are currently listed
in the ``Discontinued Drug Product List'' section of the Orange Book.
Winifred M. Begley submitted a citizen petition dated September 10,
2015 (Docket No. FDA-2015-P-3319), under 21 CFR 10.30, requesting that
the Agency determine whether MEVACOR (lovastatin) tablets, 20 mg and 40
mg, were withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that MEVACOR (lovastatin) tablets, 20 mg and 40 mg,
were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
MEVACOR (lovastatin) tablets, 20 mg and 40 mg, were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of MEVACOR (lovastatin)
tablets, 20 mg and 40 mg, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have found no information that would indicate that
this product was withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list MEVACOR (lovastatin)
tablets, 20 mg and 40 mg, in the ``Discontinued Drug Product List''
section of the Orange Book. The ``Discontinued Drug Product List''
delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to MEVACOR (lovastatin) tablets, 20 mg and 40
mg. Additional ANDAs that refer to these products may also be approved
by the Agency as long as they meet all other legal and regulatory
requirements for the approval of ANDAs. If FDA determines that labeling
for these drug products should be revised to meet current standards,
the Agency will advise ANDA applicants to submit such labeling.
Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01096 Filed 1-20-16; 8:45 am]
BILLING CODE 4164-01-P