[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Withdrawn From Sale for Reasons of Safety or Effectiveness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7.5 mg/vial, were not withdrawn from sale for reasons of safety or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