Determination That Product Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness:

Federal Register Volume 76, Number 108 (Monday, June 6, 2011)

Notices

Pages 32366-32367

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

FR Doc No: 2011-13884

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket Nos. FDA-2007-P-0347 formerly 2007P-0431/CP1 and FDA-2010-P- 0505

Determination That ORLAAM (Levomethadyl Acetate Hydrochloride)

Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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

ORLAAM (levomethadyl acetate hydrochloride (HCl)) oral solution, 10 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for levomethadyl acetate HCl oral solution, 10 mg/mL, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Sandra Park, Center for Drug

Evaluation and Research, Food and Drug Administration, 10903 New

Hampshire Ave., Bldg. 51, rm. 6221, 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 approved 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)(1) (21 CFR 314.161(a)(1)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug.

ORLAAM (levomethadyl acetate HCl) oral solution, 10 mg/mL, is the subject of NDA 20-315, held by Roxane Laboratories, Inc. (Roxane), and approved on July 9, 1993. ORLAAM is indicated for the management of opiate dependence, reserved for use in treatment of opiate-addicted patients who fail to show an acceptable response to other adequate treatments for opiate addiction, either because of insufficient effectiveness or the inability to achieve effective dose due to intolerable adverse effects from those drugs.

In a letter dated April 10, 2003, Roxane notified FDA that ORLAAM

(levomethadyl acetate HCl) oral solution, 10 mg/mL, was being discontinued, and FDA moved the drug product to the ``Discontinued Drug

Product List'' section of the Orange Book. In the Federal Register of

November 7, 2007 (72 FR 62858), FDA

Page 32367

announced that it was withdrawing approval of NDA 20-315, effective

December 7, 2007.

Charles O'Keeffe of the Virginia Commonwealth University School of

Medicine submitted two citizen petitions, one dated October 31, 2007

(Docket No. FDA-2007-P-0347), and the second dated September 22, 2010

(Docket No. FDA-2010-P-0505), under 21 CFR 10.30, requesting that the agency determine whether ORLAAM (levomethadyl acetate HCl) oral solution, 10 mg/mL, was withdrawn from sale for reasons of safety or effectiveness.

After considering the citizen petition and reviewing agency records, FDA has determined under Sec. 314.161 that ORLAAM

(levomethadyl acetate HCl) oral solution, 10 mg/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that ORLAAM (levomethadyl acetate HCl) oral solution, 10 mg/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of ORLAAM (levomethadyl acetate HCl) oral solution, 10 mg/mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the agency will continue to list ORLAAM (levomethadyl acetate HCl) oral solution, 10 mg/mL, 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 ORLAAM (levomethadyl acetate HCl) oral solution, 10 mg/mL, 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: May 31, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

FR Doc. 2011-13884 Filed 6-3-11; 8:45 am

BILLING CODE 4160-01-P