83_FR_28976 83 FR 28856 - Novartis Pharmaceuticals Corporation, et al.; Withdrawal of Approval of Five New Drug Applications

83 FR 28856 - Novartis Pharmaceuticals Corporation, et al.; Withdrawal of Approval of Five New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 120 (June 21, 2018)

Page Range28856-28857
FR Document2018-13293

The Food and Drug Administration (FDA or Agency) is withdrawing approval of five new drug applications (NDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Federal Register, Volume 83 Issue 120 (Thursday, June 21, 2018) 
[Federal Register Volume 83, Number 120 (Thursday, June 21, 2018)]
[Notices]
[Pages 28856-28857]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13293]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2194]


Novartis Pharmaceuticals Corporation, et al.; Withdrawal of 
Approval of Five New Drug Applications

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 five new drug applications (NDAs) from multiple 
applicants. The holders of the applications notified the Agency in 
writing that the drug products were no longer marketed and requested 
that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of July 23, 2018.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in 
the table have informed FDA that these drug products are no longer 
marketed and have requested that FDA withdraw approval of the 
applications under the process in Sec.  314.150(c) (21 CFR 314.150(c)). 
The applicants have also, by their requests, waived their opportunity 
for a hearing. Withdrawal of approval of an application or abbreviated 
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 020831.............  Foradil Aerolizer        Novartis
                          (formoterol fumarate)    Pharmaceuticals
                          Powder, 0.012            Corp., One Health
                          milligram (mg)/          Pl., East Hanover, NJ
                          inhalation.              07936.
NDA 022504.............  Axiron (testosterone)    Eli Lilly and Co.,
                          Transdermal Metered      Lilly Corporate
                          Solution, 30 mg/1.5      Center, Indianapolis,
                          milliliter (mL)          IN 46285.
                          actuation.
NDA 050585.............  Rocephin (ceftriaxone    Hoffmann-La Roche,
                          sodium) for Injection,   Inc., c/o Genentech,
                          equivalent to (EQ) 10    Inc., 1 DNA Way,
                          gram (g) base/vial, EQ   South San Francisco,
                          250 mg base/vial (IV/    CA 94080.
                          IM), EQ 500 mg base/
                          vial (IV/IM), EQ 1 g
                          base/vial (IV/IM), EQ
                          2 g base/vial (IV/IM),
                          EQ 500 mg base/vial, N/
                          A; N/A, 1% (Rocephin
                          kit), EQ 1 g base/
                          vial, N/A; N/A, 1%
                          (Rocephin kit).
NDA 050624.............  Rocephin (ceftriaxone    Do.
                          sodium) with Dextrose
                          in Plastic Container
                          Injection, EQ 10 mg
                          base/mL, EQ 20 mg base/
                          mL, and EQ 40 mg base/
                          mL.
NDA 202763.............  Testosterone Gel, 25 mg/ ANI Pharmaceuticals,
                          2.5 g packet, 50 mg/5    Inc., 210 Main St.
                          g packet.                West, Baudette, MN
                                                   56623.
------------------------------------------------------------------------


[[Page 28857]]

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of July 
23, 2018. Introduction or delivery for introduction into interstate 
commerce of products without approved new drug applications violates 
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 331(a) and (d)). Drug products that are listed in the table that 
are in inventory on July 23, 2018 may continue to be dispensed until 
the inventories have been depleted or the drug products have reached 
their expiration dates or otherwise become violative, whichever occurs 
first.

    Dated: June 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13293 Filed 6-20-18; 8:45 am]
 BILLING CODE 4164-01-P

28856 Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual Compounding outsourcing facility responses per burden per Total hours respondents responses respondent response Submission of adverse event reports including copy of la- beling and other information as described in the guid- ance .................................................................................. 55 1 55 1.1 61 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of Average Number of Total annual Type of recordkeeping records per burden per Total hours recordkeepers records recordkeeper recordkeeping Records of adverse events, including records of efforts to obtain the data elements for each adverse event report 55 1 55 16 880 1 There are no capital costs or operating and maintenance costs associated with this collection of information. This is the first extension of the Dated: June 14, 2018. longer marketed and requested that the information collection and we have Leslie Kux, approval of the applications be retained the currently approved burden Associate Commissioner for Policy. withdrawn. estimate. Based on our review of Agency [FR Doc. 2018–13294 Filed 6–20–18; 8:45 am] DATES: Approval is withdrawn as of July data, we estimate that annually 55 BILLING CODE 4164–01–P 23, 2018. outsourcing facilities (‘‘Number of Respondents’’ and ‘‘Total Annual FOR FURTHER INFORMATION CONTACT: Responses’’ in table 1) will submit DEPARTMENT OF HEALTH AND Florine P. Purdie, Center for Drug adverse event reports to FDA as HUMAN SERVICES Evaluation and Research, Food and Drug Administration, 10903 New specified in the guidance and that Food and Drug Administration Hampshire Ave., Bldg. 51, Rm. 6248, preparing and submitting this [Docket No. FDA–2018–N–2194] Silver Spring, MD 20993–0002, 301– information will take approximately 1.1 796–3601. hours per registrant (‘‘Average Burden Novartis Pharmaceuticals Corporation, SUPPLEMENTARY INFORMATION: The per Response’’ in table 1). Likewise, we et al.; Withdrawal of Approval of Five holders of the applications listed in the estimate that annually 55 outsourcing New Drug Applications table have informed FDA that these drug facilities (‘‘Number of Recordkeepers’’ in table 2) will maintain records of AGENCY: Food and Drug Administration, products are no longer marketed and adverse events as specified in the HHS. have requested that FDA withdraw ACTION: Notice. approval of the applications under the guidance and that preparing and process in § 314.150(c) (21 CFR maintaining the records will take SUMMARY: The Food and Drug 314.150(c)). The applicants have also, approximately 16 hours per registrant by their requests, waived their Administration (FDA or Agency) is (‘‘Average Burden per Recordkeeping’’ withdrawing approval of five new drug opportunity for a hearing. Withdrawal in table 2). applications (NDAs) from multiple of approval of an application or applicants. The holders of the abbreviated application under applications notified the Agency in § 314.150(c) is without prejudice to writing that the drug products were no refiling. Application No. Drug Applicant NDA 020831 ...... Foradil Aerolizer (formoterol fumarate) Powder, 0.012 milli- Novartis Pharmaceuticals Corp., One Health Pl., East Han- gram (mg)/inhalation. over, NJ 07936. NDA 022504 ...... Axiron (testosterone) Transdermal Metered Solution, 30 mg/ Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 1.5 milliliter (mL) actuation. 46285. NDA 050585 ...... Rocephin (ceftriaxone sodium) for Injection, equivalent to Hoffmann-La Roche, Inc., c/o Genentech, Inc., 1 DNA Way, (EQ) 10 gram (g) base/vial, EQ 250 mg base/vial (IV/IM), South San Francisco, CA 94080. EQ 500 mg base/vial (IV/IM), EQ 1 g base/vial (IV/IM), EQ 2 g base/vial (IV/IM), EQ 500 mg base/vial, N/A; N/A, 1% (Rocephin kit), EQ 1 g base/vial, N/A; N/A, 1% (Rocephin kit). NDA 050624 ...... Rocephin (ceftriaxone sodium) with Dextrose in Plastic Con- Do. amozie on DSK3GDR082PROD with NOTICES1 tainer Injection, EQ 10 mg base/mL, EQ 20 mg base/mL, and EQ 40 mg base/mL. NDA 202763 ...... Testosterone Gel, 25 mg/2.5 g packet, 50 mg/5 g packet ...... ANI Pharmaceuticals, Inc., 210 Main St. West, Baudette, MN 56623. VerDate Sep<11>2014 17:22 Jun 20, 2018 Jkt 244001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\21JNN1.SGM 21JNN1

Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices 28857 Therefore, approval of the electronic mail to dhsdeskofficer@ Estimated Total Annual Respondent applications listed in the table, and all omb.eop.gov. Cost: $7,978.50. amendments and supplements thereto, FOR FURTHER INFORMATION CONTACT: Estimated Respondents’ Operation is hereby withdrawn as of July 23, 2018. Requests for additional information or and Maintenance Costs: $0. Introduction or delivery for introduction copies of the information collection Estimated Respondents’ Capital and into interstate commerce of products should be made to Director, Information Start-Up Costs: $0. without approved new drug Estimated Total Annual Cost to the Management Division, 500 C Street SW, applications violates section 301(a) and Federal Government: $28,899.24. Washington, DC 20472, email address (d) of the Federal Food, Drug, and FEMA-Information-Collections- Comments Cosmetic Act (21 U.S.C. 331(a) and (d)). Management@fema.dhs.gov or Clarence Drug products that are listed in the table Comments may be submitted as (Smiley) White, Chief, Operations and indicated in the ADDRESSES caption that are in inventory on July 23, 2018 Support Branch, United States Fire may continue to be dispensed until the above. Comments are solicited to (a) Administration, 301–447–1055 or by evaluate whether the proposed data inventories have been depleted or the email at Smiley.White@fema.dhs.gov. drug products have reached their collection is necessary for the proper SUPPLEMENTARY INFORMATION: This performance of the agency, including expiration dates or otherwise become proposed information collection violative, whichever occurs first. whether the information shall have previously published in the Federal practical utility; (b) evaluate the Dated: June 14, 2018. Register on February 22, 2018 at 83 FR accuracy of the agency’s estimate of the Leslie Kux, 7752 with a 60 day public comment burden of the proposed collection of Associate Commissioner for Policy. period. FEMA received two anonymous information, including the validity of [FR Doc. 2018–13293 Filed 6–20–18; 8:45 am] public comments that were not relevant the methodology and assumptions used; BILLING CODE 4164–01–P to the information collection. The (c) enhance the quality, utility, and purpose of this notice is to notify the clarity of the information to be public that FEMA will submit the collected; and (d) minimize the burden information collection abstracted below of the collection of information on those DEPARTMENT OF HOMELAND to the Office of Management and Budget who are to respond, including through SECURITY for review and clearance. the use of appropriate automated, Federal Emergency Management Collection of Information electronic, mechanical, or other Agency technological collection techniques or Title: Transcript Request Form. [Docket ID: FEMA–2018–0009; OMB No. Type of Information Collection: New other forms of information technology, 1660—NEW] information collection. e.g., permitting electronic submission of OMB Number: 1660—NEW. responses. Agency Information Collection Form Titles and Numbers: FEMA Rachel Frier, Activities: Submission for OMB Form 064–0–0–12, Transcript Request Records Management Branch Chief, Office Review; Comment Request; Transcript Form. of the Chief Administrative Officer, Mission Request Form Abstract: FEMA provides training to Support, Federal Emergency Management advance the professional development Agency, Department of Homeland Security. AGENCY: Federal Emergency of personnel engaged in fire prevention Management Agency, DHS. [FR Doc. 2018–13291 Filed 6–20–18; 8:45 am] and control and emergency management ACTION: Notice and request for activities through its Center for BILLING CODE 9111–45–P comments. Domestic Preparedness (CDP), SUMMARY: The Federal Emergency Emergency Management Institute (EMI), DEPARTMENT OF HOMELAND Management Agency (FEMA) will National Fire Academy (NFA), National SECURITY submit the information collection Training and Education Division, abstracted below to the Office of National Domestic Preparedness Federal Emergency Management Management and Budget for review and Consortium, and Rural Domestic Agency clearance in accordance with the Preparedness Consortium. FEMA collects information from students who [Docket ID: FEMA–2018–0024; OMB No. requirements of the Paperwork 1660–0140] Reduction Act of 1995. The submission have completed courses at the National will describe the nature of the Fire Academy (NFA) and the Emergency Agency Information Collection information collection, the categories of Management Institute (EMI) for the Activities: Proposed Collection; respondents, the estimated burden (i.e., purpose of fulfilling the student’s Comment Request; Integrated Public the time, effort and resources used by request to provide a copy of their Alert and Warning Systems (IPAWS) respondents to respond) and cost, and transcript for their personal records Memorandum of Agreement the actual data collection instruments and/or for transmittal to an institution Applications FEMA will use. of higher education that delivers training and education also in support AGENCY: Federal Emergency DATES: Comments must be submitted on Management Agency, DHS. of the FEMA mission. or before July 23, 2018. Affected Public: Individuals or ACTION: Notice and request for ADDRESSES: Submit written comments households; Business or other for-profit; comments. on the proposed information collection Not-for-profit institutions; State, Local amozie on DSK3GDR082PROD with NOTICES1 to the Office of Information and or Tribal Government. SUMMARY: The Federal Emergency Regulatory Affairs, Office of Estimated Number of Respondents: Management Agency, as part of its Management and Budget. Comments 4,500. continuing effort to reduce paperwork should be addressed to the Desk Officer Estimated Number of Responses: and respondent burden, invites the for the Department of Homeland 4,500. general public to take this opportunity Security, Federal Emergency Estimated Total Annual Burden to comment on an extension, without Management Agency, and sent via Hours: 225 hours. change, of a currently approved VerDate Sep<11>2014 17:22 Jun 20, 2018 Jkt 244001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\21JNN1.SGM 21JNN1


Document Created: 2018-06-21 01:23:39
Document Modified: 2018-06-21 01:23:39
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.
DatesApproval is withdrawn as of July 23, 2018.
ContactFlorine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301- 796-3601.
FR Citation83 FR 28856 
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