[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]


-----------------------------------------------------------------------

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Withdrawn From Sale for Reasons of Safety or Effectiveness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not withdrawn from sale for reasons of safety or effectiveness.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