Determinations that Drugs were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:

Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)

Notices

Pages 53908-53909

From the Federal Register Online via the Government Printing Office [www.gpo.gov]

FR Doc No: 2011-22143

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Release Tablets, 7.5 Milligrams and 15 Milligrams, Were Not Withdrawn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.

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OPANA ER (oxymorphone hydrochloride (HCl)) extended-release tablets, 7.5 milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness.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