82_FR_56834 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

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)

Page Range56606-56607
FR Document2017-25771

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 Issue 228 (Wednesday, November 29, 2017) 
[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DATES: The approval is withdrawn as of November 29, 2017.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

56606 Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices September 18, 2015, or access the Subsequent to this approval, the USPTO CFR 60.30), any interested person may information at: https://www.gpo.gov/ received a patent term restoration petition FDA for a determination fdsys/pkg/FR-2015-09-18/pdf/2015- application for XURIDEN (U.S. Patent regarding whether the applicant for 23389.pdf. No. 6,258,795) from Wellstat extension acted with due diligence Docket: For access to the docket to Therapeutics Corp., and the USPTO during the regulatory review period. To read background documents or the requested FDA’s assistance in meet its burden, the petition must electronic and written/paper comments determining this patent’s eligibility for comply with all the requirements of 21 received, go to https:// patent term restoration. In a letter dated CFR 60.30, including but not limited to: www.regulations.gov and insert the August 25, 2016, FDA advised the Must be timely (see DATES), must be docket number, found in brackets in the USPTO that this human drug product filed in accordance with 21 CFR 10.20, heading of this document, into the had undergone a regulatory review must contain sufficient facts to merit an ‘‘Search’’ box and follow the prompts period and that the approval of FDA investigation, and must certify that and/or go to the Dockets Management XURIDEN represented the first a true and complete copy of the petition Staff, 5630 Fishers Lane, Rm. 1061, permitted commercial marketing or use has been served upon the patent Rockville, MD 20852. of the product. Thereafter, the USPTO applicant. (See H. Rept. 857, part 1, 98th FOR FURTHER INFORMATION CONTACT: requested that FDA determine the Cong., 2d sess., pp. 41–42, 1984.) Beverly Friedman, Office of Regulatory product’s regulatory review period. Petitions should be in the format Policy, Food and Drug Administration, II. Determination of Regulatory Review specified in 21 CFR 10.30. 10903 New Hampshire Ave., Bldg. 51, Period Submit petitions electronically to Rm. 6250, Silver Spring, MD 20993, https://www.regulations.gov at Docket 301–796–3600. FDA has determined that the No. FDA–2013–S–0610. Submit written applicable regulatory review period for petitions (two copies are required) to the SUPPLEMENTARY INFORMATION: XURIDEN is 8,494 days. Of this time, Dockets Management Staff (HFA–305), I. Background 8,254 days occurred during the testing Food and Drug Administration, 5630 phase of the regulatory review period, Fishers Lane, Rm. 1061, Rockville, MD The Drug Price Competition and while 240 days occurred during the 20852. Patent Term Restoration Act of 1984 approval phase. These periods of time (Pub. L. 98–417) and the Generic Dated: November 24, 2017. were derived from the following dates: Animal Drug and Patent Term 1. The date an exemption under Leslie Kux, Restoration Act (Pub. L. 100–670) section 505(i) of the Federal Food, Drug, Associate Commissioner for Policy. generally provide that a patent may be and Cosmetic Act (the FD&C Act) (21 [FR Doc. 2017–25770 Filed 11–28–17; 8:45 am] extended for a period of up to 5 years U.S.C. 355(i)) became effective: June 4, BILLING CODE 4164–01–P so long as the patented item (human 1992. The applicant claims May 4, 1992, drug product, animal drug product, as the date the investigational new drug medical device, food additive, or color application (IND) became effective. DEPARTMENT OF HEALTH AND additive) was subject to regulatory However, FDA records indicate that the HUMAN SERVICES review by FDA before the item was IND effective date was June 4, 1992, marketed. Under these acts, a product’s which was 30 days after FDA receipt of Food and Drug Administration regulatory review period forms the basis the IND. [Docket No. FDA–2017–N–6373] for determining the amount of extension 2. The date the application was an applicant may receive. initially submitted with respect to the Roxane Laboratories, Inc.; Withdrawal A regulatory review period consists of human drug product under section of Approval of a New Drug Application two periods of time: A testing phase and 505(b) of the FD&C Act: January 8, 2015. for ROXICODONE (Oxycodone an approval phase. For human drug FDA has verified the applicant’s claim Hydrochloride) Sustained-Release products, the testing phase begins when that the new drug application (NDA) for Tablets, 10 Milligrams and 30 the exemption to permit the clinical XURIDEN (NDA 208169) was initially Milligrams investigations of the drug becomes submitted on January 8, 2015. effective and runs until the approval 3. The date the application was AGENCY: Food and Drug Administration, phase begins. The approval phase starts approved: September 4, 2015. FDA has HHS. with the initial submission of an verified the applicant’s claim that NDA ACTION: Notice. application to market the human drug 208169 was approved on September 4, product and continues until FDA grants SUMMARY: The Food and Drug 2015. Administration (FDA or Agency) is permission to market the drug product. This determination of the regulatory Although only a portion of a regulatory withdrawing approval of new drug review period establishes the maximum review period may count toward the application (NDA) 020932 for potential length of a patent extension. actual amount of extension that the ROXICODONE (oxycodone However, the USPTO applies several Director of USPTO may award (for hydrochloride (HCl)) Sustained-Release statutory limitations in its calculations example, half the testing phase must be Tablets, 10 milligrams (mg) and 30 mg, of the actual period for patent extension. subtracted as well as any time that may held by Roxane Laboratories, Inc. In its application for patent extension, have occurred before the patent was (Roxane). Roxane requested withdrawal this applicant seeks 5 years of patent issued), FDA’s determination of the of this application and waived its term extension. pmangrum on DSK3GDR082PROD with NOTICES1 length of a regulatory review period for opportunity for a hearing. a human drug product will include all III. Petitions DATES: The approval is withdrawn as of of the testing phase and approval phase Anyone with knowledge that any of November 29, 2017. as specified in 35 U.S.C. 156(g)(1)(B). the dates as published are incorrect may FOR FURTHER INFORMATION CONTACT: FDA has approved for marketing the submit either electronic or written Kristiana Brugger, Office of Regulatory human drug product XURIDEN (uridine comments and, under 21 CFR 60.24, ask Policy, Center for Drug Evaluation and triacetate). XURIDEN is indicated for the for a redetermination (see DATES). Research, Food and Drug treatment of hereditary orotic aciduria. Furthermore, as specified in § 60.30 (21 Administration, 10903 New Hampshire VerDate Sep<11>2014 15:19 Nov 28, 2017 Jkt 241001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1

Federal Register / Vol. 82, No. 228 / Wednesday, November 29, 2017 / Notices 56607 Ave., Bldg. 51, Rm. 6262, Silver Spring, Dated: November 24, 2017. including attachments, to https:// MD 20993, 301–796–3601. Leslie Kux, www.regulations.gov will be posted to Associate Commissioner for Policy. the docket unchanged. Because your SUPPLEMENTARY INFORMATION: NDA comment will be made public, you are [FR Doc. 2017–25771 Filed 11–28–17; 8:45 am] 020932 for ROXICODONE SR solely responsible for ensuring that your BILLING CODE 4164–01–P (oxycodone HCl) Sustained-Release comment does not include any Tablets, 10 mg and 30 mg, was received confidential information that you or a on December 29, 1997, and approved on DEPARTMENT OF HEALTH AND third party may not wish to be posted, October 26, 1998, as safe and effective HUMAN SERVICES such as medical information, your or ‘‘for the management of moderate to anyone else’s Social Security number, or severe pain where use of an opioid Food and Drug Administration confidential business information, such analgesic is appropriate for more than a [Docket No. FDA–2017–D–5570] as a manufacturing process. Please note few days’’ (see approval letter, available that if you include your name, contact at https://www.accessdata.fda.gov/ Select Updates for Recommendations information, or other information that drugsatfda_docs/appletter/1998/ for Clinical Laboratory Improvement identifies you in the body of your 20932ltr.pdf). (FDA has verified the Amendments of 1988 Waiver comments, that information will be Web site addresses as of the date this Applications for Manufacturers of In posted on https://www.regulations.gov. document publishes in the Federal Vitro Diagnostic Devices; Draft • If you want to submit a comment Register, but Web sites are subject to Guidance for Industry and Food and with confidential information that you change over time.) FDA later Drug Administration Staff; Availability do not wish to be made available to the determined, however, that this public, submit the comment as a AGENCY: Food and Drug Administration, written/paper submission and in the application had serious deficiencies. HHS. Accordingly, on February 3, 2000, FDA manner detailed (see ‘‘Written/Paper ACTION: Notice of availability. Submissions’’ and ‘‘Instructions’’). granted Roxane’s request for a stay of the effective date of the approval of SUMMARY: The Food and Drug Written/Paper Submissions NDA 020932 until such time as: (1) Administration (FDA or Agency) is Submit written/paper submissions as Roxane submits additional data; (2) FDA announcing the availability of the draft follows: has reviewed those data; and (3) FDA guidance entitled ‘‘Select Updates for • Mail/Hand delivery/Courier (for has determined that the submitted data Recommendations for Clinical written/paper submissions): Dockets support a finding of safety and Laboratory Improvement Amendments Management Staff (HFA–305), Food and effectiveness without reliance on of 1988 (CLIA) Waiver Applications for Drug Administration, 5630 Fishers investigations to which Roxane does not Manufacturers of In Vitro Diagnostic Lane, Rm. 1061, Rockville, MD 20852. have a right of reference.1 Roxane has Devices.’’ FDA has developed this draft • For written/paper comments not submitted any additional guidance to implement a section of the submitted to the Dockets Management information to support approval of NDA 21st Century Cures Act (Cures Act) that Staff, FDA will post your comment, as 020932, nor has it submitted any annual requires FDA to revise ‘‘V. well as any attachments, except for reports for this NDA since 2002. The Demonstrating Insignificant Risk of an information submitted, marked and product has never been marketed.2 Erroneous Result—Accuracy’’ of the identified, as confidential, if submitted Roxane requested that FDA withdraw guidance ‘‘Recommendations for as detailed in ‘‘Instructions.’’ approval of NDA 020932 for Clinical Laboratory Improvement Instructions: All submissions received Amendments of 1988 (CLIA) Waiver must include the Docket No. FDA– ROXICODONE (oxycodone HCl) Applications for Manufacturers of In 2017–D–5570 for ‘‘Recommendations Sustained Release Tablets, and waived Vitro Diagnostic Devices’’ (‘‘2008 CLIA for Clinical Laboratory Improvement the opportunity for a hearing concerning Waiver Guidance’’) that was issued on Amendments of 1988 (CLIA) Waiver this action. January 30, 2008. This draft guidance Applications for Manufacturers of In For the reasons discussed above, updates FDA’s thinking regarding the Vitro Diagnostic Devices.’’ Received approval of NDA 020932, and all appropriate use of comparable comments will be placed in the docket amendments and supplements thereto, performance between a waived user and and, except for those submitted as is withdrawn. Distribution of a moderately complex laboratory user to ‘‘Confidential Submissions,’’ publicly ROXICODONE (oxycodone HCl) demonstrate accuracy. This draft viewable at https://www.regulations.gov Sustained-Release Tablets, 10 mg and 30 guidance is not final nor is it in effect or at the Dockets Management Staff mg, in interstate commerce without an at this time. between 9 a.m. and 4 p.m., Monday approved application is illegal and DATES: Submit either electronic or through Friday. subject to regulatory action (see sections written comments on the draft guidance • Confidential Submissions—To 505(a) and 301(d) of the FD&C Act (21 by January 29, 2018 to ensure that the submit a comment with confidential U.S.C. 355(a) and 331(d)). Agency considers your comment on this information that you do not wish to be draft guidance before it begins work on made publicly available, submit your 1 February 3, 2000 FDA Response to Citizen the final version of the guidance. comments only as a written/paper Petition and Petition for Stay of Action, Docket ADDRESSES: You may submit comments submission. You should submit two FDA–1999–P–2921, available at https:// on any guidance at any time as follows: copies total. One copy will include the pmangrum on DSK3GDR082PROD with NOTICES1 www.regulations.gov/document?D=FDA-1999-P- information you claim to be confidential 2921-0014. Electronic Submissions 2 Reflecting their non-marketed status, with a heading or cover note that states ROXICODONE (oxycodone HCl) Sustained-Release Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS Tablets, 10 mg and 30 mg, are on the ‘‘Discontinued following way: CONFIDENTIAL INFORMATION.’’ The Drug Products’’ list in the Orange Book, where the • Federal eRulemaking Portal: Agency will review this copy, including drug is listed as ‘‘Roxicodone’’ and described as ‘‘extended release’’ (see https:// https://www.regulations.gov. Follow the the claimed confidential information, in www.accessdata.fda.gov/scripts/cder/ob/results_ instructions for submitting comments. its consideration of comments. The product.cfm?Appl_Type=N&Appl_No=020932). Comments submitted electronically, second copy, which will have the VerDate Sep<11>2014 15:19 Nov 28, 2017 Jkt 241001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\29NON1.SGM 29NON1


Document Created: 2017-11-29 01:26:30
Document Modified: 2017-11-29 01:26:30
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe approval is withdrawn as of November 29, 2017.
ContactKristiana Brugger, Office of Regulatory Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6262, Silver Spring, MD 20993, 301-796-3601.
FR Citation82 FR 56606 
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