[Federal Register Volume 79, Number 195 (Wednesday, October 8, 2014)]
[Notices]
[Page 60852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-23961]
[[Page 60852]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-1609]
Determination That LUPRON DEPOT (Leuprolide Acetate for Depot
Suspension), Injectable 3.75 Milligrams/Vial Was Not Withdrawn From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) has determined that
LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable 3.75
milligrams (mg)/vial, was not withdrawn from sale for reasons of safety
or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for LUPRON DEPOT (leuprolide
acetate for depot suspension), Injectable 3.75 mg/vial, if all other
legal and regulatory requirements are met. However, in considering
whether to file an ANDA for leuprolide acetate for depot suspension,
future applicants are advised that they may not be able to obtain
LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable 3.75
mg/vial, for bioequivalence testing because the product has not been
commercially available for a number of years. An ANDA applicant who is
unable to obtain LUPRON DEPOT (leuprolide acetate for depot
suspension), Injectable 3.75 mg/vial, for bioequivalence testing should
contact the Office of Generic Drugs for a determination of what is
necessary to show bioavailability and the same therapeutic effect.
FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 240-402-0979.
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). FDA may not approve an ANDA that does not refer
to a listed drug.
LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable
3.75 mg/vial, is the subject of NDA2001, held by Abbvie Endocrine, Inc.
(Abbvie), and initially approved on October 22, 1990. LUPRON DEPOT is
indicated for management of endometriosis, including pain relief and
reduction of endometriotic lesions. LUPRON DEPOT, concomitantly with
iron therapy, is also indicated for the preoperative hematologic
improvement of patients with anemia caused by uterine leiomyomata.
In a report dated December 15, 1999, Abbvie notified FDA that
LUPRON DEPOT (leuprolide acetate for depot suspension), Injectable 3.75
mg/vial, was being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
Terri Nataline, on behalf of Lachman Consultant Services, Inc.,
submitted a citizen petition dated November 25, 2013 (Docket No. FDA-
2013-P-1609), under 21 CFR 10.30, requesting, in part, that the Agency
determine whether LUPRON DEPOT, Injectable 3.75 mg/vial, was 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 LUPRON DEPOT, Injectable 3.75 mg/vial, was not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that LUPRON DEPOT,
Injectable 3.75 mg/vial, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of LUPRON DEPOT, Injectable 3.75 mg/vial,
from sale. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events. We have reviewed the
available evidence and determined that the products were not withdrawn
from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list LUPRON DEPOT,
Injectable 3.75 mg/vial, 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 LUPRON DEPOT, Injectable 3.75 mg/
vial, 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: October 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-23961 Filed 10-7-14; 8:45 am]
BILLING CODE 4164-01-P