[Federal Register Volume 76, Number 108 (Monday, June 6, 2011)]
[Notices]
[Pages 32366-32367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13884]


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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Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale 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.

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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milligrams (mg)/milliliter (mL), was not withdrawn from sale for 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