[Federal Register Volume 79, Number 161 (Wednesday, August 20, 2014)]
[Notices]
[Pages 49327-49328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-19713]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-1510]


Determination That LUPRON DEPOT-PED (Leuprolide Acetate for Depot 
Suspension), Injectable 3.75 Milligrams/Vial and 7.5 Milligrams/Vial; 
and LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension), 
Injectable 7.5 Milligrams/Vial and 7.5 Milligrams/Vial, 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Withdrawn From Sale for Reasons of Safety or Effectiveness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) has determined that 
LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 
3.75 milligrams (mg)/vial and 7.5 mg/vial; and LUPRON DEPOT-PED 
(leuprolide acetate for depot suspension), Injectable 7.5 mg/vial and 
7.5 mg/vial, were not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to approve abbreviated 
new drug applications (ANDAs) for leuprolide acetate for depot 
suspension, injectable 3.75 mg/vial and 7.5 mg/vial; and injectable 7.5 
mg/vial and 7.5 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-PED (leuprolide acetate for 
depot suspension), Injectable 3.75 mg/vial and 7.5 mg/vial; or LUPRON 
DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/
vial and 7.5 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-PED (leuprolide acetate 
for depot suspension), Injectable 3.75 mg/vial and 7.5 mg/vial; or 
LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 
7.5 mg/vial and 7.5 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 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.

[[Page 49328]]

    LUPRON DEPOT-PED (leuprolide acetate for depot suspension), 
Injectable 3.75 mg/vial and 7.5 mg/vial; and LUPRON DEPOT-PED 
(leuprolide acetate for depot suspension), Injectable 7.5 mg/vial and 
7.5 mg/vial, are the subject of NDA 020263, held by Abbvie Endocrine, 
Inc., and initially approved on April 16, 1993. LUPRON DEPOT-PED is 
indicated for treatment of children with central precocious puberty.
    In a report dated January 30, 1999, Abbvie notified FDA that LUPRON 
DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75 
mg/vial and 7.5 mg/vial; and LUPRON DEPOT-PED (leuprolide acetate for 
depot suspension), Injectable 7.5 mg/vial and 7.5 mg/vial, were being 
discontinued, and FDA moved the drug products to the ``Discontinued 
Drug Product List'' section of the Orange Book.
    Joan Janulis, on behalf of Lachmann Consultant Services, Inc., 
submitted a citizen petition dated November 4, 2013 (Docket No. FDA-
2013-P-1510), under 21 CFR 10.30, requesting that the Agency determine 
whether LUPRON DEPOT-PED, Injectable 3.75 mg/vial and 7.5 mg/vial; and 
LUPRON DEPOT-PED, Injectable 7.5 mg/vial and 7.5 mg/vial, 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 LUPRON DEPOT-PED, Injectable 3.75 mg/vial and 
7.5 mg/vial; and LUPRON DEPOT-PED, Injectable 7.5 mg/vial and 7.5 mg/
vial, were not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
LUPRON DEPOT-PED, Injectable 3.75 mg/vial and 7.5 mg/vial; or LUPRON 
DEPOT-PED, Injectable 7.5 mg/vial and 7.5 mg/vial, were withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of LUPRON DEPOT-PED, 
Injectable 3.75 mg/vial and 7.5 mg/vial; and LUPRON DEPOT-PED, 
Injectable 7.5 mg/vial and 7.5 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-PED, 
Injectable 3.75 mg/vial and 7.5 mg/vial; and LUPRON DEPOT-PED, 
Injectable 7.5 mg/vial and 7.5 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-PED, Injectable 3.75 
mg/vial and 7.5 mg/vial; or LUPRON DEPOT-PED, Injectable 7.5 mg/vial 
and 7.5 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: August 14, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-19713 Filed 8-19-14; 8:45 am]
BILLING CODE 4164-01-P