Document ID: FDA-2014-N-0198-0002
Agency: fda
Document Type: Notice
Title: Xanodyne Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 8 New Drug Applications and 46 Abbreviated New Drug Applications for Propoxyphene Products; Correction
Posted Date: 2016-04-15T04:00Z

[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Page 22283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08689]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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