82 FR 56606 - Roxane Laboratories, Inc.; Withdrawal of Approval of a New Drug Application for ROXICODONE (Oxycodone Hydrochloride) Sustained-Release Tablets, 10 Milligrams and 30 Milligrams

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 228 (November 29, 2017)

The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) 020932 for ROXICODONE (oxycodone hydrochloride (HCl)) Sustained-Release Tablets, 10 milligrams (mg) and 30 mg, held by Roxane Laboratories, Inc. (Roxane). Roxane requested withdrawal of this application and waived its opportunity for a hearing.

[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Pages 56606-56607]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25771]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6373]


Roxane Laboratories, Inc.; Withdrawal of Approval of a New Drug 
Application for ROXICODONE (Oxycodone Hydrochloride) Sustained-Release 
Tablets, 10 Milligrams and 30 Milligrams

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of new drug application (NDA) 020932 for 
ROXICODONE (oxycodone hydrochloride (HCl)) Sustained-Release Tablets, 
10 milligrams (mg) and 30 mg, held by Roxane Laboratories, Inc. 
(Roxane). Roxane requested withdrawal of this application and waived 
its opportunity for a hearing.

DATES: The approval is withdrawn as of November 29, 2017.

FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Office of 
Regulatory Policy, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire

[[Page 56607]]

Ave., Bldg. 51, Rm. 6262, Silver Spring, MD 20993, 301-796-3601.

SUPPLEMENTARY INFORMATION: NDA 020932 for ROXICODONE SR (oxycodone HCl) 
Sustained-Release Tablets, 10 mg and 30 mg, was received on December 
29, 1997, and approved on October 26, 1998, as safe and effective ``for 
the management of moderate to severe pain where use of an opioid 
analgesic is appropriate for more than a few days'' (see approval 
letter, available at https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20932ltr.pdf). (FDA has verified the Web site addresses 
as of the date this document publishes in the Federal Register, but Web 
sites are subject to change over time.) FDA later determined, however, 
that this application had serious deficiencies. Accordingly, on 
February 3, 2000, FDA granted Roxane's request for a stay of the 
effective date of the approval of NDA 020932 until such time as: (1) 
Roxane submits additional data; (2) FDA has reviewed those data; and 
(3) FDA has determined that the submitted data support a finding of 
safety and effectiveness without reliance on investigations to which 
Roxane does not have a right of reference.\1\ Roxane has not submitted 
any additional information to support approval of NDA 020932, nor has 
it submitted any annual reports for this NDA since 2002. The product 
has never been marketed.\2\ Roxane requested that FDA withdraw approval 
of NDA 020932 for ROXICODONE (oxycodone HCl) Sustained Release Tablets, 
and waived the opportunity for a hearing concerning this action.
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    \1\ February 3, 2000 FDA Response to Citizen Petition and 
Petition for Stay of Action, Docket FDA-1999-P-2921, available at 
https://www.regulations.gov/document?D=FDA-1999-P-2921-0014.
    \2\ Reflecting their non-marketed status, ROXICODONE (oxycodone 
HCl) Sustained-Release Tablets, 10 mg and 30 mg, are on the 
``Discontinued Drug Products'' list in the Orange Book, where the 
drug is listed as ``Roxicodone'' and described as ``extended 
release'' (see https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=020932).
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    For the reasons discussed above, approval of NDA 020932, and all 
amendments and supplements thereto, is withdrawn. Distribution of 
ROXICODONE (oxycodone HCl) Sustained-Release Tablets, 10 mg and 30 mg, 
in interstate commerce without an approved application is illegal and 
subject to regulatory action (see sections 505(a) and 301(d) of the 
FD&C Act (21 U.S.C. 355(a) and 331(d)).

    Dated: November 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25771 Filed 11-28-17; 8:45 am]
 BILLING CODE 4164-01-P