[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]]

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

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Suspension), Injectable 3.75 Milligrams/Vial Was Not Withdrawn From 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.

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

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milligrams (mg)/vial, was not withdrawn from sale for reasons of safety 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