[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Products Covered by New Drug Application 21-610 Were Not Withdrawn From 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withdrawn from sale for reasons of safety or effectiveness.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