[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Pages 53908-53909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-22143]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-P-0182 and FDA-2011-P-0209]


Determination That OPANA ER (Oxymorphone Hydrochloride) Extended-
Release Tablets, 7.5 Milligrams and 15 Milligrams, Were Not Withdrawn 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 tablets, 
7.5 milligrams (mg) and 15 mg, were not withdrawn from sale for reasons 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, 7.5 mg and 15 mg, if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Nam Kim, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, rm. 6320, Silver Spring, MD 20993-0002, 301-796-3601.

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 only clinical data 
required in an ANDA are data to show that the drug that is the subject 
of the ANDA is bioequivalent to the listed drug.
    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).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must 
determine whether a listed drug was withdrawn from sale for reasons of 
safety or effectiveness: (1) Before an ANDA that refers to that listed 
drug may be approved; (2) whenever a listed drug is voluntarily 
withdrawn from sale and ANDAs that refer to the listed drug have been 
approved; and (3) when a person petitions for such a determination 
under Sec. Sec.  10.25(a) and 10.30 (21 CFR 10.25(a) and 10.30). 
Section 314.161(d) provides that if FDA determines that a listed drug 
was withdrawn from sale for reasons of safety or effectiveness, the 
Agency will initiate proceedings that could result in the withdrawal of 
approval of the ANDAs that refer to the listed drug.
    OPANA ER (oxymorphone HCl) extended-release tablets, 7.5 mg and 15 
mg, are the subject of NDA 021610, held by Endo Pharmaceuticals, and 
initially approved on June 22, 2006. OPANA ER is indicated for the 
relief of moderate to severe pain in patients requiring continuous, 
around-the-clock opioid treatment for an extended period of time.
    OPANA ER (oxymorphone HCl) extended-release tablets, 7.5 mg and 15 
mg, are currently listed in the ``Discontinued Drug Product List'' 
section of the Orange Book. There are approved ANDAs for oxymorphone 
HCl extended-release tablets, 7.5 mg and 15 mg; these ANDAs are listed 
in the Orange Book. The other strengths of OPANA ER--both lower and 
higher strengths than 7.5 mg and 15 mg--continue to be marketed.
    Watson Laboratories, Inc., submitted a citizen petition dated March 
21, 2011 (Docket No. FDA-2011-P-0182), under Sec.  10.30, requesting 
that the Agency determine whether OPANA ER (oxymorphone HCl) extended-
release tablets, 7.5 mg and 15 mg, were voluntarily withdrawn from sale 
for reasons of safety or effectiveness. In addition, K&L Gates 
submitted a citizen petition dated March 25, 2011 (Docket No. FDA-2011-
P-0209), under Sec.  10.30, requesting that the Agency determine that 
OPANA ER (oxymorphone HCl) extended-release tablets, 7.5 mg and 15

[[Page 53909]]

mg, were not discontinued from sale for reasons of safety or 
effectiveness.
    After considering the citizen petitions and reviewing Agency 
records and based on the information we have at this time, FDA has 
determined under Sec.  314.161 that OPANA ER (oxymorphone HCl) 
extended-release tablets, 7.5 mg and 15 mg, were not withdrawn for 
reasons of safety or effectiveness. The petitioners have identified no 
data or other information suggesting that OPANA ER (oxymorphone HCl) 
extended-release tablets, 7.5 mg and 15 mg, were withdrawn for reasons 
of safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of OPANA ER (oxymorphone HCl) 
extended-release tablets, 7.5 mg and 15 mg, from sale. We have also 
independently evaluated relevant literature and data for possible 
postmarketing adverse events. In addition, we have considered that the 
7.5 mg and 15 mg strengths are bracketed by other strengths that are 
still being marketed. We have found no information that would indicate 
that OPANA ER (oxymorphone HCl) extended-release tablets, 7.5 mg and 15 
mg, were withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list OPANA ER (oxymorphone 
HCl) extended-release tablets, 7.5 mg and 15 mg, 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. 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, 7.5 mg and 15 mg, 
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 this drug product should be revised to meet current 
standards, the Agency will advise ANDA applicants to submit such 
labeling.

    Dated: August 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-22143 Filed 8-29-11; 8:45 am]
BILLING CODE 4160-01-P