[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)]
[Notices]
[Pages 72728-72729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29639]
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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Withdrawn From Sale for Reasons of Safety or Effectiveness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.
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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not withdrawn from sale for reasons of safety or effectiveness.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