Determination That CEDAX (Ceftibuten Dihydrate) for Oral Suspension, 90 Milligrams/5 Milliliters and 180 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 16599-16600 [2017-06701]

Download as PDF Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–0001] Food and Drug Administration/Xavier University Medical Device Conference (MedCon) AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ‘‘FDA/Xavier University Medical Device Conference (MedCon).’’ This 3-day public conference includes presentations from key FDA officials and industry experts with small group break-out sessions. The conference is intended for companies of all sizes and employees at all levels. DATES: The public conference will be held on May 3, 2017, from 8:30 a.m. to 5 p.m.; May 4, 2017, from 8:30 a.m. to 5 p.m.; and May 5, 2017, from 8:30 a.m. to 12:30 p.m. ADDRESSES: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513–745–3016. FOR FURTHER INFORMATION CONTACT: For information regarding this notice: Gina Brackett, Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237, 513–679–2700, FAX: 513–679–2771, email: gina.brackett@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier Health, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207–5471, 513–745– 3073, email: phillipsm4@xavier.edu or visit https://www.XavierMedCon.com. SUPPLEMENTARY INFORMATION: The public conference helps fulfill the Department of Health and Human Services’ and FDA’s important mission to protect the public health. The conference will provide those engaged in FDA-regulated medical devices (for humans) with information on the following topics: • Center Director Corner: Strategic Priorities for 2017 and Beyond. • European Union (EU) Regulations— Exploring the Unknown. • Impact of the New EU Regulations on Your Global Regulatory Strategy. • Digital Health—Key Focus Areas for FDA and Industry. • Office of Compliance Strategic Priorities. jstallworth on DSK7TPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 15:11 Apr 04, 2017 Jkt 241001 • Update from the Office of Device Evaluation. • FDA Insight on the 510(k) Modifications Guidance. • 510(k) Modifications: To submit or not to submit? • Your Contract Manufacturer Received a Warning Letter. What Now? • Defending Claims for Your Device. • The Impact of Cultural Misalignment . . . . and the Path Forward. • The Importance of Quality and Regulatory throughout the Merger and Acquisition Lifecycle—Landmines or Opportunities. • What to Expect with FDA’s Program Alignment? • Investigator Insights and Breaking News. FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. The conference helps to achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The conference also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121) by providing outreach activities by Government Agencies to small businesses. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, and lunches for the 3 days of the conference. There will be onsite registration. The cost of registration is as follows: TABLE 1—REGISTRATION FEES1 16599 To register by mail, please send your name, title, firm name, address, telephone, email, and payment information for the fee to Xavier University, Attention: Marla Phillips, 3800 Victory Pkwy., Cincinnati, OH 45207–5471. An email will be sent confirming your registration. Attendees are responsible for their own accommodations. The conference headquarter hotel is the Downtown Cincinnati Hilton Netherlands Plaza, 35 West 5th St., Cincinnati, OH, 45202, 513–421–9100. Special Conference Block rates are available through April 11, 2017. To make reservations online, please visit the ‘‘Venue/Logistics’’ link at https://www.XavierMedCon.com. If you need special accommodations due to a disability, please contact Marla Phillips (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the conference. Dated: March 29, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–06699 Filed 4–4–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–P–3560] Determination That CEDAX (Ceftibuten Dihydrate) for Oral Suspension, 90 Milligrams/5 Milliliters and 180 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that CEDAX (ceftibuten Industry ......................................... 1,695 dihydrate) for oral suspension, 90 Small Business (<100 employees) 1,200 milligrams (mg)/5 milliliters (mL) and Start-up Manufacturer ................... $300 180 mg/5 mL, were not withdrawn from Academic ...................................... $300 sale for reasons of safety or FDA/Government Employee ......... Free effectiveness. This determination will 1 The following forms of payment will be acallow FDA to approve abbreviated new cepted: American Express, Visa, MasterCard, drug applications (ANDAs) for and company checks. ceftibuten dihydrate for oral suspension, 90 mg/5 mL and 180 mg/5 mL, if all To register online for the public other legal and regulatory requirements conference, please visit the are met. ‘‘Registration’’ link on the conference Web site at https:// FOR FURTHER INFORMATION CONTACT: www.XavierMedCon.com. FDA has Anuj Shah, Center for Drug Evaluation verified the Web site address, but is not and Research, Food and Drug responsible for subsequent changes to Administration, 10903 New Hampshire the Web site after this document Ave., Bldg. 51, Rm. 6228, Silver Spring, publishes in the Federal Register. MD 20993–0002, 301–796–2246. PO 00000 Standard rate Attendee type Frm 00030 Fmt 4703 Sfmt 4703 SUMMARY: E:\FR\FM\05APN1.SGM 05APN1 16600 Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. CEDAX (ceftibuten dihydrate) for oral suspension, 90 mg/5 mL and 180 mg/5 mL, are the subject of NDA 050686, held by Pernix Therapeutics LLC, and initially approved on December 20, 1995. CEDAX is indicated for the treatment of individuals with mild-tomoderate infections caused by susceptible strains of Haemophilus influenzae (including b-lactamaseproducing strains), Moraxella catarrhalis (including b-lactamaseproducing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only) in acute bacterial exacerbations of chronic bronchitis; H. influenzae (including b-lactamaseproducing strains), M. catarrhalis (including b-lactamase-producing strains), or S. pneumoniae (penicillinsusceptible strains only) in acute jstallworth on DSK7TPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 15:11 Apr 04, 2017 Jkt 241001 bacterial otitis media; and S. pyogenes in pharyngitis and tonsillitis. CEDAX (ceftibuten dihydrate) for oral suspension, 90 mg/5 mL and 180 mg/5 mL, are currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Orchid Healthcare (a division of Orchid Pharma, Ltd.) submitted a citizen petition dated October 26, 2016 (Docket No. FDA–2016–P–3560), under 21 CFR 10.30, requesting that the Agency determine whether CEDAX (ceftibuten dihydrate) for oral suspension, 90 mg/5 mL and 180 mg/5 mL, were withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that CEDAX (ceftibuten dihydrate) for oral suspension, 90 mg/5 mL and 180 mg/5 mL, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that these drug products were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of CEDAX (ceftibuten dihydrate) for oral suspension, 90 mg/5 mL and 180 mg/5 mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that these drug products were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list CEDAX (ceftibuten dihydrate) for oral suspension, 90 mg/5 mL and 180 mg/5 mL, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to these drug products may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: March 30, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–06701 Filed 4–4–17; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council for Biomedical Imaging and Bioengineering. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Council for Biomedical Imaging and Bioengineering. Date: May 18, 2017. Open: 8:30 a.m. to 12:00 p.m. Agenda: Report from the Institute Director, other Institute Staff and scientific presentation. Place: The William F. Bolger Center, Franklin Building, Classroom 1, 9600 Newbridge Drive, Potomac, MD 20854. Closed: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications and/or proposals. Place: The William F. Bolger Center, Franklin Building, Classroom 1, 9600 Newbridge Drive, Potomac, MD 20854. Contact Person: David T. George, Ph.D., Acting Associate Director, Office of Research Administration, National Institute of Biomedical Imaging and Bioengineering, 6707 Democracy Boulevard, Room 920, Bethesda, MD 20892. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: https:// www.nibib1.nih.gov/about/NACBIB/ E:\FR\FM\05APN1.SGM 05APN1

Agencies

[Federal Register Volume 82, Number 64 (Wednesday, April 5, 2017)]
[Notices]
[Pages 16599-16600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06701]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-P-3560]


Determination That CEDAX (Ceftibuten Dihydrate) for Oral 
Suspension, 90 Milligrams/5 Milliliters and 180 Milligrams/5 
Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or 
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that CEDAX (ceftibuten dihydrate) for oral suspension, 90 
milligrams (mg)/5 milliliters (mL) and 180 mg/5 mL, were not withdrawn 
from sale for reasons of safety or effectiveness. This determination 
will allow FDA to approve abbreviated new drug applications (ANDAs) for 
ceftibuten dihydrate for oral suspension, 90 mg/5 mL and 180 mg/5 mL, 
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Anuj Shah, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301-796-2246.

[[Page 16600]]


SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products under an ANDA procedure. ANDA applicants 
must, with certain exceptions, show that the drug for which they are 
seeking approval contains the same active ingredient in the same 
strength and dosage form as the ``listed drug,'' which is a version of 
the drug that was previously approved. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products With Therapeutic 
Equivalence Evaluations,'' which is known generally as the ``Orange 
Book.'' Under FDA regulations, drugs are removed from the list if the 
Agency withdraws or suspends approval of the drug's NDA or ANDA for 
reasons of safety or effectiveness or if FDA determines that the listed 
drug was withdrawn from sale for reasons of safety or effectiveness (21 
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness. This determination 
may be made at any time after the drug has been withdrawn from sale, 
but must be made prior to approving an ANDA that refers to the listed 
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    CEDAX (ceftibuten dihydrate) for oral suspension, 90 mg/5 mL and 
180 mg/5 mL, are the subject of NDA 050686, held by Pernix Therapeutics 
LLC, and initially approved on December 20, 1995. CEDAX is indicated 
for the treatment of individuals with mild-to-moderate infections 
caused by susceptible strains of Haemophilus influenzae (including 
[beta]-lactamase-producing strains), Moraxella catarrhalis (including 
[beta]-lactamase-producing strains), or Streptococcus pneumoniae 
(penicillin-susceptible strains only) in acute bacterial exacerbations 
of chronic bronchitis; H. influenzae (including [beta]-lactamase-
producing strains), M. catarrhalis (including [beta]-lactamase-
producing strains), or S. pneumoniae (penicillin-susceptible strains 
only) in acute bacterial otitis media; and S. pyogenes in pharyngitis 
and tonsillitis.
    CEDAX (ceftibuten dihydrate) for oral suspension, 90 mg/5 mL and 
180 mg/5 mL, are currently listed in the ``Discontinued Drug Product 
List'' section of the Orange Book.
    Orchid Healthcare (a division of Orchid Pharma, Ltd.) submitted a 
citizen petition dated October 26, 2016 (Docket No. FDA-2016-P-3560), 
under 21 CFR 10.30, requesting that the Agency determine whether CEDAX 
(ceftibuten dihydrate) for oral suspension, 90 mg/5 mL and 180 mg/5 mL, 
were withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that CEDAX (ceftibuten dihydrate) for oral 
suspension, 90 mg/5 mL and 180 mg/5 mL, were not withdrawn for reasons 
of safety or effectiveness. The petitioner has identified no data or 
other information suggesting that these drug products were withdrawn 
for reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of CEDAX (ceftibuten 
dihydrate) for oral suspension, 90 mg/5 mL and 180 mg/5 mL, from sale. 
We have also independently evaluated relevant literature and data for 
possible postmarketing adverse events. We have reviewed the available 
evidence and determined that these drug products were not withdrawn 
from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list CEDAX (ceftibuten 
dihydrate) for oral suspension, 90 mg/5 mL and 180 mg/5 mL, in the 
``Discontinued Drug Product List'' section of the Orange Book. The 
``Discontinued Drug Product List'' delineates, among other items, drug 
products that have been discontinued from marketing for reasons other 
than safety or effectiveness. ANDAs that refer to these drug products 
may be approved by the Agency as long as they meet all other legal and 
regulatory requirements for the approval of ANDAs. If FDA determines 
that labeling for these drug products should be revised to meet current 
standards, the Agency will advise ANDA applicants to submit such 
labeling.

    Dated: March 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-06701 Filed 4-4-17; 8:45 am]
BILLING CODE 4164-01-P
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