[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Page 22283]
[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,<PHONE_NUMBER>.

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.:

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    Application No.                Drug             Applicant or holder
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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.
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    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