80 FR 72728 - Determination That LIPTRUZET (Ezetimibe and Atorvastatin) Tablets, 10 Milligrams/10 Milligrams, 10 Milligrams/20 Milligrams, 10 Milligrams/40 Milligrams, and 10 Milligrams/80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 80, Issue 224 (November 20, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 224 (November 20, 2015)
| Page Range | 72728-72729 | |
| FR Document | 2015-29639 |
[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)] [Notices] [Pages 72728-72729] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29639] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-P-3404] Determination That LIPTRUZET (Ezetimibe and Atorvastatin) Tablets, 10 Milligrams/10 Milligrams, 10 Milligrams/20 Milligrams, 10 Milligrams/40 Milligrams, and 10 Milligrams/80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) has determined that LIPTRUZET (ezetimibe and atorvastatin) tablets, 10 milligrams (mg)/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ezetimibe and atorvastatin tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Kate Greenwood, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6217, 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 [[Page 72729]] 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. LIPTRUZET (ezetimibe and atorvastatin) tablets, 10 mg/10 mg, 10 mg/ 20 mg, 10 mg/40 mg, and 10 mg/80 mg, are the subject of NDA 20-0153, held by Merck Sharp & Dohme Corp., and initially approved on May 3, 2013. LIPTRUZET is indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. LIPTRUZET is also indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. In a letter dated June 1, 2015, Merck Sharpe & Dohme Corp. notified FDA that LIPTRUZET (ezetimibe and atorvastatin) tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, were being discontinued, and FDA moved the drug products to the ``Discontinued Drug Product List'' section of the Orange Book. Lupin Pharmaceuticals, Inc. submitted a citizen petition dated September 21, 2015 (Docket No. FDA-2015-P-3404), under 21 CFR 10.30, requesting that the Agency determine whether LIPTRUZET (ezetimibe and atorvastatin) tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 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 LIPTRUZET (ezetimibe and atorvastatin) tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that LIPTRUZET (ezetimibe and atorvastatin) tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/ 40 mg, and 10 mg/80 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of LIPTRUZET (ezetimibe and atorvastatin) tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 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 these products were withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list LIPTRUZET (ezetimibe and atorvastatin) tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 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. ANDAs that refer to LIPTRUZET (ezetimibe and atorvastatin) tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, may 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: November 16, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-29639 Filed 11-19-15; 8:45 am] BILLING CODE 4164-01-P
![72728 Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Notices
SUMMARY: The Food and Drug Spring, MD 20993–0002, PRAStaff@ This collection provided a baseline
Administration (FDA) is announcing fda.hhs.gov. measurement of the nation’s current
that a proposed collection of SUPPLEMENTARY INFORMATION: In food safety and food defense
information has been submitted to the compliance with 44 U.S.C. 3507, FDA capabilities; FDA wants to renew this
Office of Management and Budget has submitted the following proposed information collection to gather more
(OMB) for review and clearance under collection of information to OMB for data. By renewing this collection, FDA
the Paperwork Reduction Act of 1995. review and clearance. will be able to analyze the gaps and
DATES: Fax written comments on the trends at the State and local levels,
Improving Food Safety and Defense allowing FDA and its partners to
collection of information by December Capacity at the State and Local Level:
21, 2015. develop ways to create a national
Review of State and Local Capacities integrated food safety system.
ADDRESSES: To ensure that comments on OMB Control Number 0910–0726— FDA will conduct the survey
the information collection are received, Extension electronically, allowing FDA to conduct
OMB recommends that written streamlined analysis while creating a
The Food Safety Modernization Act
comments be faxed to the Office of low-burden, user-friendly environment
(FSMA) (Pub. L. 111–353) states that a
Information and Regulatory Affairs, for respondents to complete the survey.
review must be conducted to assess the
OMB, Attn: FDA Desk Officer, FAX: Once the results have been tabulated,
State and local capacities to show needs
202–395–7285, or emailed to oira_ FDA and its partners can assess the
for enhancement in the areas or staffing
submission@omb.eop.gov. All current progress towards an integrated
levels, laboratory capacities, and
comments should be identified with the food safety system.
information technology systems. This
OMB control number 0910–0726. Also
mandate referenced in FSMA section In the Federal Register of August 31,
include the FDA docket number found
110 stating that a review of current food 2015 (80 FR 46025), FDA published a
in brackets in the heading of this
safety and food defense capabilities 60-day notice requesting public
document.
must be presented to Congress no later comment on the proposed collection of
FOR FURTHER INFORMATION CONTACT: FDA than 2 years after the date of enactment information. No comments were
PRA Staff, Office of Operations, Food (enactment date January 4, 2011). This received.
and Drug Administration, 8455 review was completed in 2013 through FDA estimates the burden of this
Colesville Rd., COLE–14526, Silver this information collection request. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Current State and Local Government Employees ............... 1,400 1 1,400 1 1,400
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 17, 2015. (mg)/10 mg, 10 mg/20 mg, 10 mg/40 mg, is a version of the drug that was
Leslie Kux, and 10 mg/80 mg, were not withdrawn previously approved. ANDA applicants
Associate Commissioner for Policy. from sale for reasons of safety or do not have to repeat the extensive
[FR Doc. 2015–29663 Filed 11–19–15; 8:45 am] effectiveness. This determination will clinical testing otherwise necessary to
BILLING CODE 4164–01–P
allow FDA to approve abbreviated new gain approval of a new drug application
drug applications (ANDAs) for (NDA).
ezetimibe and atorvastatin tablets, 10 The 1984 amendments include what
DEPARTMENT OF HEALTH AND mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, is now section 505(j)(7) of the Federal
HUMAN SERVICES and 10 mg/80 mg, if all other legal and Food, Drug, and Cosmetic Act (21 U.S.C.
regulatory requirements are met. 355(j)(7)), which requires FDA to
Food and Drug Administration publish a list of all approved drugs.
FOR FURTHER INFORMATION CONTACT: Kate
FDA publishes this list as part of the
[Docket No. FDA–2015–P–3404] Greenwood, Center for Drug Evaluation
‘‘Approved Drug Products With
and Research, Food and Drug
Determination That LIPTRUZET Therapeutic Equivalence Evaluations,’’
Administration, 10903 New Hampshire
(Ezetimibe and Atorvastatin) Tablets, which is known generally as the
Ave., Bldg. 51, Rm. 6217, Silver Spring,
10 Milligrams/10 Milligrams, 10 ‘‘Orange Book.’’ Under FDA regulations,
MD 20993–0002, 240–402–1748.
Milligrams/20 Milligrams, 10 drugs are removed from the list if the
SUPPLEMENTARY INFORMATION: In 1984, Agency withdraws or suspends
Milligrams/40 Milligrams, and 10
Congress enacted the Drug Price approval of the drug’s NDA or ANDA
Milligrams/80 Milligrams, Were Not
Competition and Patent Term for reasons of safety or effectiveness or
Withdrawn From Sale for Reasons of
Restoration Act of 1984 (Pub. L. 98–417) if FDA determines that the listed drug
Safety or Effectiveness
(the 1984 amendments), which was withdrawn from sale for reasons of
AGENCY: Food and Drug Administration, authorized the approval of duplicate safety or effectiveness (21 CFR 314.162).
tkelley on DSK3SPTVN1PROD with NOTICES
HHS. versions of drug products under an A person may petition the Agency to
ACTION: Notice. ANDA procedure. ANDA applicants determine, or the Agency may
must, with certain exceptions, show that determine on its own initiative, whether
SUMMARY: The Food and Drug the drug for which they are seeking a listed drug was withdrawn from sale
Administration (FDA or Agency) has approval contains the same active for reasons of safety or effectiveness.
determined that LIPTRUZET (ezetimibe ingredient in the same strength and This determination may be made at any
and atorvastatin) tablets, 10 milligrams dosage form as the ‘‘listed drug,’’ which time after the drug has been withdrawn
VerDate Sep<11>2014 17:39 Nov 19, 2015 Jkt 238001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\20NON1.SGM 20NON1](https://thefederalregister.org/doc/80_FR_72952/page/1.svg)
![Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Notices 72729
from sale, but must be made prior to We have also independently evaluated 846,354, entitled, ‘‘(S,S)-trans-1,2-
approving an ANDA that refers to the relevant literature and data for possible cyclopentane Diamine-modified and
listed drug (§ 314.161 (21 CFR 314.161)). postmarketing adverse events. We have Gamma-lysine-modified Peptide
FDA may not approve an ANDA that found no information that would Nucleic Acids as Probes for Nucleic
does not refer to a listed drug. indicate that these products were Acid Detection: Synthesis and
LIPTRUZET (ezetimibe and withdrawn from sale for reasons of Applications,’’ filed 22 Sep 2006 [HHS
atorvastatin) tablets, 10 mg/10 mg, 10 safety or effectiveness. Ref No. E–308–2006/0–US–01]; US
mg/20 mg, 10 mg/40 mg, and 10 mg/80 Accordingly, the Agency will Provisional Patent Application No. 60/
mg, are the subject of NDA 20–0153, continue to list LIPTRUZET (ezetimibe 896,667, entitled, ‘‘Synthesis of Trans-
held by Merck Sharp & Dohme Corp., and atorvastatin) tablets, 10 mg/10 mg, tert-butyl-2-
and initially approved on May 3, 2013. 10 mg/20 mg, 10 mg/40 mg, and 10 mg/ aminocyclopentylcarbamate,’’ filed 23
LIPTRUZET is indicated for the 80 mg, in the ‘‘Discontinued Drug Mar 2007 [HHS Ref No. E–308–2006/1–
reduction of elevated total cholesterol Product List’’ section of the Orange US–01]; International Application PCT/
(total-C), low-density lipoprotein Book. The ‘‘Discontinued Drug Product US2007/020466, entitled, ‘‘Synthesis of
cholesterol (LDL–C), apolipoprotein B List’’ delineates, among other items, Trans-tert-butyl-2-
(Apo B), triglycerides (TG), and non- drug products that have been aminocyclopentylcarbamate,’’ filed 21
high-density lipoprotein cholesterol discontinued from marketing for reasons Sep 2007 [HHS Ref No. E–308–2006/2–
(non-HDL–C), and to increase high- other than safety or effectiveness. PCT–01]; US Patent Application No. 12/
density lipoprotein cholesterol (HDL–C) ANDAs that refer to LIPTRUZET 441,925, filed 21 Sep 2007, [HHS Ref
in patients with primary (heterozygous (ezetimibe and atorvastatin) tablets, 10 No. E–308–2006/2–US–02]; US Patent
familial and non-familial) mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, Application No. 12/409,159, entitled,
hyperlipidemia or mixed and 10 mg/80 mg, may be approved by ‘‘Cross-Coupled Peptide Nucleic Acids
hyperlipidemia. LIPTRUZET is also the Agency as long as they meet all for Detection of Nucleic Acids of
indicated for the reduction of elevated other legal and regulatory requirements Pathogens,’’ filed 23 Mar 2009 [HHS Ref
total-C and LDL–C in patients with for the approval of ANDAs. If FDA No. E–308–2006/3–US–01]; US Patent
homozygous familial determines that labeling for these drug No. 9,156,778, entitled, ‘‘Cross-Coupled
hypercholesterolemia, as an adjunct to products should be revised to meet Peptide Nucleic Acids for Detection of
other lipid-lowering treatments (e.g., current standards, the Agency will Nucleic Acids of Pathogens,’’ issued 13
LDL apheresis) or if such treatments are advise ANDA applicants to submit such Oct 2015 [HHS Ref No. E–308–2006/3–
unavailable. labeling. US–02]; US Provisional Patent
In a letter dated June 1, 2015, Merck Application No. 61/684,354, entitled,
Sharpe & Dohme Corp. notified FDA Dated: November 16, 2015.
Leslie Kux,
Cyclopentane-peptide Nucleic Acids for
that LIPTRUZET (ezetimibe and Qualitative and Quantitative Detection
atorvastatin) tablets, 10 mg/10 mg, 10 Associate Commissioner for Policy.
of Nucleic Acids,’’ filed 17 Aug 2012
mg/20 mg, 10 mg/40 mg, and 10 mg/80 [FR Doc. 2015–29639 Filed 11–19–15; 8:45 am]
[HHS Ref No. E–260–2012/0–US–01];
mg, were being discontinued, and FDA BILLING CODE 4164–01–P International Application PCT/US2013/
moved the drug products to the 055252, filed 16 Aug 2013 [HHS Ref No.
‘‘Discontinued Drug Product List’’ E–260–2012/0–PCT–02]; European
section of the Orange Book. DEPARTMENT OF HEALTH AND
Patent Application No. 13753962.3,
Lupin Pharmaceuticals, Inc. HUMAN SERVICES
filed 11 Feb 2015, [HHS Ref No E–260–
submitted a citizen petition dated 2012/0–EP–03]; Korea Patent
September 21, 2015 (Docket No. FDA– National Institutes of Health
Application No. 10–2015–7006286, filed
2015–P–3404), under 21 CFR 10.30,
Prospective Grant of Exclusive 11 Mar 2015, [HHS Ref No E–260–2012/
requesting that the Agency determine
License: Development of In Vitro 0–KR–04]; and US Patent Application
whether LIPTRUZET (ezetimibe and
Diagnostics for the Detection of No. 14/421,732, filed 13 Feb 2015, [HHS
atorvastatin) tablets, 10 mg/10 mg, 10
Diseases or Pathogenic Agents Ref No E–260–2012/0–US–05].
mg/20 mg, 10 mg/40 mg, and 10 mg/80 The patent rights in these inventions
mg, were withdrawn from sale for AGENCY: National Institute of Diabetes have been assigned to the United States
reasons of safety or effectiveness. and Digestive and Kidney Diseases, of America. Omega is seeking a
After considering the citizen petition National Institutes of Health, Public worldwide territory for this license. The
and reviewing Agency records and Health Service, HHS. field of use may be limited to use of the
based on the information we have at this ACTION: Notice.
time, FDA has determined under Patent Rights for the development and
§ 314.161 that LIPTRUZET (ezetimibe SUMMARY: This notice, in accordance sale of trans-cyclopentane-modified
and atorvastatin) tablets, 10 mg/10 mg, with 35 U.S.C. 209(c)(1) and 37 CFR peptide nucleic acids (PNA) in a
10 mg/20 mg, 10 mg/40 mg, and 10 mg/ part 404.7(a)(1)(i), that the National diagnostic system incorporating an
80 mg, were not withdrawn for reasons Institute of Diabetes and Digestive and enzyme-linked immunosorbent assay or
of safety or effectiveness. The petitioner Kidney Diseases (NIDDK), at the Omega’s proprietary VISITECT®
has identified no data or other National Institutes of Health, technology for the detection of diseases
information suggesting that LIPTRUZET Department of Health and Human or pathogenic agents including viruses
(ezetimibe and atorvastatin) tablets, 10 Services, is contemplating the grant to and microorganisms.
mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, Omega Diagnostics Group PLC DATES: Only written comments or
applications for a license (or both)
tkelley on DSK3SPTVN1PROD with NOTICES
and 10 mg/80 mg, were withdrawn for (‘‘Omega’’), a company incorporated
reasons of safety or effectiveness. We under the laws of the United Kingdom, which are received by the Technology
have carefully reviewed our files for having an office in Alva, Scotland, an Advancement Office, NIDDK, on or
records concerning the withdrawal of exclusive patent license to practice the before December 7, 2015 will be
LIPTRUZET (ezetimibe and atorvastatin) following inventions embodied in the considered.
tablets, 10 mg/10 mg, 10 mg/20 mg, 10 following patent applications: US ADDRESSES: Requests for copies of the
mg/40 mg, and 10 mg/80 mg, from sale. Provisional Patent Application No.60/ patent application, patents, inquiries,
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Document Created: 2015-12-14 13:58:44
Document Modified: 2015-12-14 13:58:44
| 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. | |
| Contact | Kate Greenwood, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002, 240- 402-1748. | |
| FR Citation | 80 FR 72728 |
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