[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and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety 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mg, were not withdrawn from sale for reasons of safety or 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