[Federal Register Volume 78, Number 122 (Tuesday, June 25, 2013)]
[Notices]
[Page 38053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-15099]
[[Page 38053]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-P-0895]
Determination That OPANA ER (Oxymorphone Hydrochloride) Drug
Products Covered by New Drug Application 21-610 Were Not Withdrawn From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
OPANA ER (oxymorphone hydrochloride (HCl)) Extended-Release Tablet
products approved under new drug application (NDA) 21-610 were not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
these drug products, and it will allow FDA to continue to approve ANDAs
for oxymorphone HCl extended-release tablets if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Patrick Raulerson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6368, Silver Spring, MD 20993-0002, 301-
796-3522.
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
U.S.C. 355(j)(7)(C); 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 before 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.
Endo submitted a citizen petition dated August 10, 2012 (Docket No.
FDA-2012-P-0895), under 21 CFR 10.30, requesting that the Agency: (1)
Determine that OPANA ER (oxymorphone hydrochloride) Extended-Release
Tablets approved under NDA 21-610 were discontinued for reasons of
safety, (2) refuse to approve any pending ANDA for a generic version of
OPANA ER approved under NDA 21-610, and (3) suspend and withdraw the
approval of any ANDA referencing OPANA ER approved under NDA 21-610 as
the reference listed drug (Petition at 1).
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 the original OPANA ER was not withdrawn for
reasons of safety or effectiveness. We describe the basis for this
determination in our letter response to Endo's citizen petition
(available on http://www.regulations.gov under Docket No. FDA-2012-P-
0895).
Accordingly, the Agency will continue to list OPANA ER (oxymorphone
HCl) Extended-Release Tablets approved under NDA 21-610 in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' includes drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. FDA will not begin procedures to withdraw approval of
ANDAs that refer to these drug products. Additional ANDAs that refer to
OPANA ER (oxymorphone HCl) Extended-Release Tablets may be approved by
the Agency as long as they meet all other legal and regulatory
requirements for the approval of ANDAs.
Dated: June 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15099 Filed 6-24-13; 8:45 am]
BILLING CODE 4160-01-P