Xanodyne Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 8 New Drug Applications and 46 Abbreviated New Drug Applications for Propoxyphene Products; Correction, 22283 [2016-08689]

Download as PDF Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR parts 210 and 211 (CGMPs), 212 (PET CGMPs), and 21 CFR part 11 (electronic records and signatures) have been approved under OMB control numbers 0910–0139, 0910–0667, and 0910–0303, respectively. III. Electronic Access Dated: April 11, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–08683 Filed 4–14–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0198] Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, http:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, http:// www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm, or http://www.regulations.gov. 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. 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 SUMMARY: 22283 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 (propoxyphene napsylate and acetaminophen) Suspension, 100 milligrams (mg)/650 mg/15 milliliters. Xanodyne Pharmaceuticals, Inc., One Riverfront Pl., Newport, KY 41071. 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide productspecific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:27 Apr 14, 2016 Jkt 238001 announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products’’ that explained the process that would be used to make productspecific BE recommendations available to the public on FDA’s Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 14, 2016. ADDRESSES: You may submit comments as follows: comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 Written/Paper Submissions E:\FR\FM\15APN1.SGM 15APN1

Agencies

[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]


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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.

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

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