81_FR_3448 81 FR 3435 - Determination That MEVACOR (Lovastatin) Tablets, 20 Milligrams and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

81 FR 3435 - Determination That MEVACOR (Lovastatin) Tablets, 20 Milligrams and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 13 (January 21, 2016)

Page Range3435-3436
FR Document2016-01096

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Administration (FDA or Agency) has determined that MEVACOR (lovastatin) tablets, 20 milligrams (mg) and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness.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.

Federal Register, Volume 81 Issue 13 (Thursday, January 21, 2016) 
[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3435-3436]
From the Federal Register Online  [www.thefederalregister.org]
[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and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety 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mg, were not withdrawn from sale for reasons of safety or 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

Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices 3435 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of Average FDA Number of Total annual 21 CFR Section or other category responses per burden per Total hours Form No. respondents responses respondent response Pre-notification Consultation or Master File FDA 3480 190 1 190 0.5 95 (concerning a food contact substance).8 Amendment to an existing notification FDA 100 1 100 0.5 50 (170.101), amendment to a Pre-notifica- 3480A. tion Consultation, or amendment to a Master File (concerning a food contact substance).9 171.1 Indirect Food Additive Petitions ........ N/A ......... 1 1 1 10,995 10,995 Use of Recycled Plastics in Food Packaging: N/A ......... 10 1 10 25 250 Chemistry Considerations. Total ........................................................ ................ ........................ ........................ ........................ .......................... 31,320 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Notifications for food contact substance formulations and food contact articles. These notifications require the submission of Form FDA 3479 (‘‘Notification for a Food Contact Substance Formulation’’) only. 3 Duplicate notifications for uses of food contact substances. 4 Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions. 5 Notifications for uses that are the subject of moderately complex food additive petitions. 6 Notifications for uses that are the subject of very complex food additive petitions. 7 These notifications require the submission of Form FDA 3480. 8 These notifications recommend the submission of Form FDA 3480. 9 These notifications recommend the submission of Form FDA 3480A. The estimates in table 1 are based on reporting burden of 150 hours per Dated: January 14, 2016. our current experience with the food response, for a total burden of 5,700 Leslie Kux, contact substance notification program hours. Associate Commissioner for Policy. and informal communication with In row 6 we estimate 190 respondents [FR Doc. 2016–01102 Filed 1–20–16; 8:45 am] industry. Beginning in row 1 we estimate 10 will submit information to a pre- BILLING CODE 4164–01–P respondents will submit two notification consultation or a master file notifications annually for food contact in support of FCN submission using DEPARTMENT OF HEALTH AND substance formulations (Form FDA Form FDA 3480. We calculate a HUMAN SERVICES 3479), for a total of 20 responses. We reporting burden of 0.5 hours per calculate a reporting burden of 2 hours response, for a total burden of 95 hours. Food and Drug Administration per response, for a total of 40 hours. In In row 7 we estimate 100 respondents [Docket No. FDA–2015–P–3319] row 2 we estimate six respondents. We will submit an amendment (Form FDA believe the hourly burden for preparing 3480A) to a substantive or non- Determination That MEVACOR these notifications will primarily consist substantive request of additional (Lovastatin) Tablets, 20 Milligrams and of the manufacturer or supplier information to an incomplete FCN 40 Milligrams, Were Not Withdrawn completing Form FDA 3480, verifying submission, an amendment to a pre- From Sale for Reasons of Safety or that a previous notification is effective notification consultation, or an Effectiveness and preparing necessary documentation. amendment to a master file in support We estimate one submission for each AGENCY: Food and Drug Administration, of an FCN. We calculate a reporting respondent, for a total of six responses. HHS. burden of 0.5 hours per response, for a We calculate a reporting burden of 25 total burden of 50 hours. ACTION: Notice. hours per response, for a total of 150 hours. In row 8 we estimate one respondent SUMMARY: The Food and Drug In rows 3, 4, and 5 we identify three will submit one indirect food additive Administration (FDA or Agency) has tiers of FCNs that reflect different levels petition under § 171.1, for a total of one determined that MEVACOR (lovastatin) of burden applicable to the respective response. We calculate a reporting tablets, 20 milligrams (mg) and 40 mg, information collection items (denoted as burden of 10,995 hours per response, for were not withdrawn from sale for Categories C, D, and E). We estimate 6 a total burden of 10,995 hours. reasons of safety or effectiveness. This respondents will submit 2 Category C determination means that FDA will not Finally, in row 9 we estimate ten begin procedures to withdraw approval submissions annually, for a total of 12 respondents will utilize the responses. We calculate a reporting of abbreviated new drug applications recommendations in the guidance (ANDAs) that refer to these drug burden of 120 hours per response, for a document entitled, ‘‘Use of Recycled total burden of 1,440 hours. We estimate products, and it will allow FDA to asabaliauskas on DSK9F6TC42PROD with NOTICES Plastics in Food Packaging: Chemistry continue to approve ANDAs that refer to 42 respondents will submit 2 Category Considerations,’’ to develop the the products as long as they meet D submissions annually, for a total of 84 responses. We calculate a reporting additional information for one such relevant legal and regulatory burden of 150 hours per response, for a submission annually, for a total of 10 requirements. total burden of 12,600 hours. We responses. We calculate a reporting FOR FURTHER INFORMATION CONTACT: Kate estimate 38 respondents will submit burden of 25 hours per response, for a Greenwood, Center for Drug Evaluation 1Category E submission annually, for a total burden of 250 hours. and Research, Food and Drug total of 38 responses. We calculate a Administration, 10903 New Hampshire VerDate Sep<11>2014 18:26 Jan 20, 2016 Jkt 238001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\21JAN1.SGM 21JAN1

3436 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices Ave., Bldg. 51, Rm. 6286, Silver Spring, LDL–C to target levels; and (3) as an safety or effectiveness. FDA will not MD 20993–0002, 240–402–1748. adjunct to diet for the reduction of begin procedures to withdraw approval SUPPLEMENTARY INFORMATION: In 1984, elevated total-C and LDL–C levels in of approved ANDAs that refer to Congress enacted the Drug Price patients with primary MEVACOR (lovastatin) tablets, 20 mg Competition and Patent Term hypercholesterolemia (Types IIa and and 40 mg. Additional ANDAs that refer Restoration Act of 1984 (Pub. L. 98–417) IIb), when the response to diet restricted to these products may also be approved (the 1984 amendments), which in saturated fat and cholesterol and to by the Agency as long as they meet all authorized the approval of duplicate other nonpharmacological measures other legal and regulatory requirements versions of drug products under an alone has been inadequate. MEVACOR for the approval of ANDAs. If FDA ANDA procedure. ANDA applicants is also indicated as an adjunct to diet to determines that labeling for these drug must, with certain exceptions, show that reduce total-C, LDL–C, and products should be revised to meet the drug for which they are seeking apolipoprotein B levels in adolescent current standards, the Agency will approval contains the same active boys and girls who are at least 1 year advise ANDA applicants to submit such ingredient in the same strength and post-menarche, 10–17 years of age, with labeling. dosage form as the ‘‘listed drug,’’ which heterozygous familial Dated: January 14, 2016. is a version of the drug that was hypercholesterolemia if, after an Leslie Kux, previously approved. ANDA applicants adequate trial of diet therapy, the following findings are present: (1) LDL– Associate Commissioner for Policy. do not have to repeat the extensive [FR Doc. 2016–01096 Filed 1–20–16; 8:45 am] clinical testing otherwise necessary to C remains >189 mg/deciliter (dL) or (2) gain approval of a new drug application LDL–C remains >160 mg/dL and there is BILLING CODE 4164–01–P (NDA). a positive family history of premature The 1984 amendments include what cardiovascular disease (CVD) or two or more other CVD risk factors are present DEPARTMENT OF HEALTH AND is now section 505(j)(7) of the Federal HUMAN SERVICES Food, Drug, and Cosmetic Act (21 U.S.C. in the adolescent patient. MEVACOR (lovastatin) tablets, 20 mg 355(j)(7)), which requires FDA to Food and Drug Administration and 40 mg, are currently listed in the publish a list of all approved drugs. ‘‘Discontinued Drug Product List’’ [Docket No. FDA–2008–D–0611] FDA publishes this list as part of the section of the Orange Book. ‘‘Approved Drug Products With Winifred M. Begley submitted a Submission and Review of Sterility Therapeutic Equivalence Evaluations,’’ citizen petition dated September 10, Information in Premarket Notification which is known generally as the 2015 (Docket No. FDA–2015–P–3319), (510(k)) Submissions for Devices ‘‘Orange Book.’’ Under FDA regulations, under 21 CFR 10.30, requesting that the Labeled as Sterile; Guidance for drugs are removed from the list if the Agency determine whether MEVACOR Industry and Food and Drug Agency withdraws or suspends (lovastatin) tablets, 20 mg and 40 mg, Administration Staff; Availability approval of the drug’s NDA or ANDA were withdrawn from sale for reasons of for reasons of safety or effectiveness or safety or effectiveness. AGENCY: Food and Drug Administration, if FDA determines that the listed drug After considering the citizen petition HHS. was withdrawn from sale for reasons of and reviewing Agency records and ACTION: Notice of availability. safety or effectiveness (21 CFR 314.162). based on the information we have at this A person may petition the Agency to SUMMARY: The Food and Drug time, FDA has determined under determine, or the Agency may Administration (FDA or Agency) is § 314.161 that MEVACOR (lovastatin) determine on its own initiative, whether announcing the availability of the tablets, 20 mg and 40 mg, were not a listed drug was withdrawn from sale guidance entitled ‘‘Submission and withdrawn for reasons of safety or for reasons of safety or effectiveness. Review of Sterility Information in effectiveness. The petitioner has This determination may be made at any Premarket Notification (510(k)) identified no data or other information time after the drug has been withdrawn suggesting that MEVACOR (lovastatin) Submissions for Devices Labeled as from sale, but must be made prior to tablets, 20 mg and 40 mg, were Sterile.’’ This guidance updates and approving an ANDA that refers to the withdrawn for reasons of safety or clarifies the information regarding listed drug (§ 314.161 (21 CFR 314.161)). effectiveness. We have carefully sterilization processes that FDA FDA may not approve an ANDA that reviewed our files for records recommends sponsors include in does not refer to a listed drug. concerning the withdrawal of 510(k)s for devices labeled as sterile. MEVACOR (lovastatin) tablets, 20 mg MEVACOR (lovastatin) tablets, 20 mg This guidance document also provides and 40 mg, are the subject of NDA 19– and 40 mg, from sale. We have also details about the pyrogenicity 643, held by Merck & Co. Inc., and independently evaluated relevant information that FDA recommends initially approved on August 31, 1987. literature and data for possible sponsors include in a 510(k) MEVACOR is indicated: (1) To reduce postmarketing adverse events. We have submission. the risk of myocardial infarction, found no information that would DATES: Submit either electronic or unstable angina, and coronary indicate that this product was written comments on this guidance at revascularization procedures in withdrawn from sale for reasons of any time. General comments on Agency individuals without symptomatic safety or effectiveness. guidance documents are welcome at any cardiovascular disease, average to Accordingly, the Agency will time. The recommendations in this asabaliauskas on DSK9F6TC42PROD with NOTICES moderately elevated total cholesterol continue to list MEVACOR (lovastatin) guidance will be implemented on March (total-C) and low-density lipoprotein tablets, 20 mg and 40 mg, in the 21, 2016. cholesterol (LDL–C), and below average ‘‘Discontinued Drug Product List’’ ADDRESSES: You may submit comments high-density lipoprotein cholesterol; (2) section of the Orange Book. The as follows: to slow the progression of coronary ‘‘Discontinued Drug Product List’’ atherosclerosis in patients with delineates, among other items, drug Electronic Submissions coronary heart disease as part of a products that have been discontinued Submit electronic comments in the treatment strategy to lower total-C and from marketing for reasons other than following way: VerDate Sep<11>2014 18:26 Jan 20, 2016 Jkt 238001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\21JAN1.SGM 21JAN1


Document Created: 2018-02-02 12:33:48
Document Modified: 2018-02-02 12:33:48
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactKate Greenwood, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6286, Silver Spring, MD 20993-0002, 240-402-1748.
FR Citation81 FR 3435 
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