81_FR_22356 81 FR 22283 - Xanodyne Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 8 New Drug Applications and 46 Abbreviated New Drug Applications for Propoxyphene Products; Correction

81 FR 22283 - Xanodyne Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 8 New Drug Applications and 46 Abbreviated New Drug Applications for Propoxyphene Products; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 73 (April 15, 2016)

Page Range22283-22283
FR Document2016-08689

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of March 10, 2014 (79 FR 13308). The document withdrew approval of 8 new drug applications (NDAs) and 46 abbreviated new drug applications (ANDAs) for prescription pain medications containing propoxyphene from multiple applicants. The document failed to withdraw approval of NDA 017507, held by Xanodyne Pharmaceuticals, Inc. (Xanodyne). Xanodyne wrote to FDA asking the Agency to withdraw approval of NDA 017507 and waiving its opportunity for a hearing. FDA confirms the withdrawal of approval of NDA 017507.

Federal Register, Volume 81 Issue 73 (Friday, April 15, 2016) 
[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Page 22283]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08689]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0198]


Xanodyne Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 
8 New Drug Applications and 46 Abbreviated New Drug Applications for 
Propoxyphene Products; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of March 10, 2014 (79 FR 13308). 
The document withdrew approval of 8 new drug applications (NDAs) and 46 
abbreviated new drug applications (ANDAs) for prescription pain 
medications containing propoxyphene from multiple applicants. The 
document failed to withdraw approval of NDA 017507, held by Xanodyne 
Pharmaceuticals, Inc. (Xanodyne). Xanodyne wrote to FDA asking the 
Agency to withdraw approval of NDA 017507 and waiving its opportunity 
for a hearing. FDA confirms the withdrawal of approval of NDA 017507.

FOR FURTHER INFORMATION CONTACT: David Joy, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6254, Silver Spring, MD 20993-0002, 301-796-3601.

SUPPLEMENTARY INFORMATION: In the Federal Register of Monday, March 10, 
2014, FR Doc. 2014-05063, on page 13308, the following correction is 
made:
    On page 13308, in table 1, the following entry is added in 
numerical order by Application No.:

------------------------------------------------------------------------
    Application No.                Drug             Applicant or holder
------------------------------------------------------------------------
NDA 017507.............  Darvocet-N 100           Xanodyne
                          (propoxyphene            Pharmaceuticals,
                          napsylate and            Inc., One Riverfront
                          acetaminophen)           Pl., Newport, KY
                          Suspension, 100          41071.
                          milligrams (mg)/650 mg/
                          15 milliliters.
------------------------------------------------------------------------


    Dated: April 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08689 Filed 4-14-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices 22283 the Office of Management and Budget Dated: April 11, 2016. approval of 8 new drug applications (OMB) under the Paperwork Reduction Leslie Kux, (NDAs) and 46 abbreviated new drug Act of 1995 (44 U.S.C. 3501–3520). The Associate Commissioner for Policy. applications (ANDAs) for prescription collections of information in 21 CFR [FR Doc. 2016–08683 Filed 4–14–16; 8:45 am] pain medications containing parts 210 and 211 (CGMPs), 212 (PET BILLING CODE 4164–01–P propoxyphene from multiple applicants. CGMPs), and 21 CFR part 11 (electronic The document failed to withdraw records and signatures) have been approval of NDA 017507, held by approved under OMB control numbers DEPARTMENT OF HEALTH AND Xanodyne Pharmaceuticals, Inc. 0910–0139, 0910–0667, and 0910–0303, HUMAN SERVICES (Xanodyne). Xanodyne wrote to FDA respectively. asking the Agency to withdraw approval Food and Drug Administration of NDA 017507 and waiving its III. Electronic Access [Docket No. FDA–2014–N–0198] opportunity for a hearing. FDA confirms the withdrawal of approval of NDA Persons with access to the Internet 017507. Xanodyne Pharmaceuticals, Inc., et al.; may obtain the document at either Withdrawal of Approval of 8 New Drug FOR FURTHER INFORMATION CONTACT: http://www.fda.gov/Drugs/Guidance Applications and 46 Abbreviated New ComplianceRegulatoryInformation/ David Joy, Center for Drug Evaluation Drug Applications for Propoxyphene and Research, Food and Drug Guidances/default.htm, http:// Products; Correction Administration, 10903 New Hampshire www.fda.gov/BiologicsBloodVaccines/ AGENCY: Food and Drug Administration, Ave., Bldg. 51, Rm. 6254, Silver Spring, GuidanceComplianceRegulatory HHS. MD 20993–0002, 301–796–3601. Information/default.htm, http:// www.fda.gov/AnimalVeterinary/ ACTION: Notice; correction. SUPPLEMENTARY INFORMATION: In the GuidanceComplianceEnforcement/ Federal Register of Monday, March 10, GuidanceforIndustry/default.htm, or SUMMARY: The Food and Drug 2014, FR Doc. 2014–05063, on page Administration (FDA) is correcting a 13308, the following correction is made: http://www.regulations.gov. notice that appeared in the Federal On page 13308, in table 1, the Register of March 10, 2014 (79 FR following entry is added in numerical 13308). The document withdrew order by Application No.: Application No. Drug Applicant or holder NDA 017507 ...... Darvocet-N 100 (propoxyphene napsylate and acetamino- Xanodyne Pharmaceuticals, Inc., One Riverfront Pl., New- phen) Suspension, 100 milligrams (mg)/650 mg/15 milli- port, KY 41071. liters. Dated: April 11, 2016. announced the availability of a guidance comment does not include any Leslie Kux, for industry entitled ‘‘Bioequivalence confidential information that you or a Associate Commissioner for Policy. Recommendations for Specific third party may not wish to be posted, [FR Doc. 2016–08689 Filed 4–14–16; 8:45 am] Products’’ that explained the process such as medical information, your or BILLING CODE 4164–01–P that would be used to make product- anyone else’s Social Security number, or specific BE recommendations available confidential business information, such to the public on FDA’s Web site. The BE as a manufacturing process. Please note DEPARTMENT OF HEALTH AND recommendations identified in this that if you include your name, contact HUMAN SERVICES notice were developed using the process information, or other information that described in that guidance. identifies you in the body of your Food and Drug Administration DATES: Although you can comment on comments, that information will be any guidance at any time (see 21 CFR posted on http://www.regulations.gov. [Docket No. FDA–2007–D–0369] 10.115(g)(5)), to ensure that the Agency • If you want to submit a comment Product-Specific Bioequivalence considers your comment on this draft with confidential information that you Recommendations; Draft and Revised guidance before it begins work on the do not wish to be made available to the Draft Guidances for Industry; final version of the guidance, submit public, submit the comment as a Availability either electronic or written comments written/paper submission and in the on the draft guidance by June 14, 2016. manner detailed (see ‘‘Written/Paper AGENCY: Food and Drug Administration, ADDRESSES: You may submit comments Submissions’’ and ‘‘Instructions’’). HHS. as follows: Written/Paper Submissions ACTION: Notice of availability. Electronic Submissions Submit written/paper submissions as SUMMARY: The Food and Drug Submit electronic comments in the follows: Administration (FDA or Agency) is following way: • Mail/Hand delivery/Courier (for announcing the availability of • Federal eRulemaking Portal: http:// written/paper submissions): Division of asabaliauskas on DSK3SPTVN1PROD with NOTICES additional draft and revised draft www.regulations.gov. Follow the Dockets Management (HFA–305), Food product-specific bioequivalence (BE) instructions for submitting comments. and Drug Administration, 5630 Fishers recommendations. The Comments submitted electronically, Lane, Rm. 1061, Rockville, MD 20852. recommendations provide product- including attachments, to http:// • For written/paper comments specific guidance on the design of BE www.regulations.gov will be posted to submitted to the Division of Dockets studies to support abbreviated new drug the docket unchanged. Because your Management, FDA will post your applications (ANDAs). In the Federal comment will be made public, you are comment, as well as any attachments, Register of June 11, 2010, FDA solely responsible for ensuring that your except for information submitted, VerDate Sep<11>2014 17:27 Apr 14, 2016 Jkt 238001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\15APN1.SGM 15APN1


Document Created: 2016-04-15 00:55:04
Document Modified: 2016-04-15 00:55:04
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; correction.
ContactDavid Joy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6254, Silver Spring, MD 20993-0002, 301-796-3601.
FR Citation81 FR 22283 
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