82_FR_16663 82 FR 16599 - 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(Ceftibuten Dihydrate) for Oral Suspension, 90 Milligrams/5 Milliliters and 180 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

82 FR 16599 - 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(Ceftibuten Dihydrate) for Oral Suspension, 90 Milligrams/5 Milliliters and 180 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 64 (April 5, 2017)

Page Range16599-16600
FR Document2017-06701

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that CEDAX (ceftibuten dihydrate) for oral suspension, 90 milligrams (mg)/5 milliliters (mL) and 180 mg/5 mL, were not withdrawn from sale for reasons of safety or effectiveness.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.

Federal Register, Volume 82 Issue 64 (Wednesday, April 5, 2017) 
[Federal Register Volume 82, Number 64 (Wednesday, April 5, 2017)]
[Notices]
[Pages 16599-16600]
From the Federal Register Online  [www.thefederalregister.org]
[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Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or 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.

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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milligrams (mg)/5 milliliters (mL) and 180 mg/5 mL, were not withdrawn 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

Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices 16599 DEPARTMENT OF HEALTH AND • Update from the Office of Device To register by mail, please send your HUMAN SERVICES Evaluation. name, title, firm name, address, • FDA Insight on the 510(k) telephone, email, and payment Food and Drug Administration Modifications Guidance. information for the fee to Xavier [Docket No. FDA–2017–N–0001] • 510(k) Modifications: To submit or University, Attention: Marla Phillips, not to submit? 3800 Victory Pkwy., Cincinnati, OH Food and Drug Administration/Xavier • Your Contract Manufacturer 45207–5471. An email will be sent University Medical Device Conference Received a Warning Letter. What Now? confirming your registration. (MedCon) • Defending Claims for Your Device. Attendees are responsible for their • The Impact of Cultural own accommodations. The conference AGENCY: Food and Drug Administration, Misalignment . . . . and the Path headquarter hotel is the Downtown HHS. Forward. Cincinnati Hilton Netherlands Plaza, 35 ACTION: Notice of public conference. • The Importance of Quality and West 5th St., Cincinnati, OH, 45202, Regulatory throughout the Merger and 513–421–9100. Special Conference SUMMARY: The Food and Drug Acquisition Lifecycle—Landmines or Block rates are available through April Administration (FDA) Cincinnati Opportunities. 11, 2017. To make reservations online, District, in co-sponsorship with Xavier • What to Expect with FDA’s Program please visit the ‘‘Venue/Logistics’’ link University, is announcing a public Alignment? at http://www.XavierMedCon.com. If conference entitled ‘‘FDA/Xavier • Investigator Insights and Breaking you need special accommodations due University Medical Device Conference News. to a disability, please contact Marla (MedCon).’’ This 3-day public FDA has made education of the drug conference includes presentations from Phillips (see FOR FURTHER INFORMATION and device manufacturing community a CONTACT) at least 7 days in advance of key FDA officials and industry experts high priority to help ensure the quality with small group break-out sessions. the conference. of FDA-regulated drugs and devices. The conference is intended for The conference helps to achieve Dated: March 29, 2017. companies of all sizes and employees at objectives set forth in section 406 of the Anna K. Abram, all levels. Food and Drug Administration Deputy Commissioner for Policy, Planning, DATES: The public conference will be Modernization Act of 1997 (21 U.S.C. Legislation, and Analysis. held on May 3, 2017, from 8:30 a.m. to 393), which includes working closely [FR Doc. 2017–06699 Filed 4–4–17; 8:45 am] 5 p.m.; May 4, 2017, from 8:30 a.m. to with stakeholders and maximizing the BILLING CODE 4164–01–P 5 p.m.; and May 5, 2017, from 8:30 a.m. availability and clarity of information to to 12:30 p.m. stakeholders and the public. The ADDRESSES: The public conference will conference also is consistent with the DEPARTMENT OF HEALTH AND be held on the campus of Xavier Small Business Regulatory Enforcement HUMAN SERVICES University, 3800 Victory Pkwy., Fairness Act of 1996 (Pub. L. 104–121) Cincinnati, OH 45207, 513–745–3016. Food and Drug Administration by providing outreach activities by FOR FURTHER INFORMATION CONTACT: Government Agencies to small [Docket No. FDA–2016–P–3560] For information regarding this notice: businesses. Gina Brackett, Food and Drug Registration: There is a registration Determination That CEDAX (Ceftibuten Administration, 6751 Steger Dr., fee. The conference registration fees Dihydrate) for Oral Suspension, 90 Cincinnati, OH 45237, 513–679–2700, cover the cost of the presentations, Milligrams/5 Milliliters and 180 FAX: 513–679–2771, email: training materials, receptions, Milligrams/5 Milliliters, Were Not gina.brackett@fda.hhs.gov. breakfasts, and lunches for the 3 days of Withdrawn From Sale for Reasons of For information regarding the the conference. There will be onsite Safety or Effectiveness conference and registration: Marla registration. The cost of registration is as Phillips, Xavier Health, Xavier AGENCY: Food and Drug Administration, follows: HHS. University, 3800 Victory Pkwy., Cincinnati, OH 45207–5471, 513–745– TABLE 1—REGISTRATION FEES1 ACTION: Notice. 3073, email: phillipsm4@xavier.edu or SUMMARY: The Food and Drug visit http://www.XavierMedCon.com. Standard Attendee type rate Administration (FDA or Agency) has SUPPLEMENTARY INFORMATION: The determined that CEDAX (ceftibuten public conference helps fulfill the Industry ......................................... 1,695 dihydrate) for oral suspension, 90 Department of Health and Human Small Business (<100 employees) 1,200 milligrams (mg)/5 milliliters (mL) and Services’ and FDA’s important mission Start-up Manufacturer ................... $300 180 mg/5 mL, were not withdrawn from to protect the public health. The Academic ...................................... $300 sale for reasons of safety or conference will provide those engaged FDA/Government Employee ......... Free effectiveness. This determination will in FDA-regulated medical devices (for 1 The following forms of payment will be ac- allow FDA to approve abbreviated new humans) with information on the cepted: American Express, Visa, MasterCard, drug applications (ANDAs) for following topics: and company checks. ceftibuten dihydrate for oral suspension, • Center Director Corner: Strategic To register online for the public 90 mg/5 mL and 180 mg/5 mL, if all Priorities for 2017 and Beyond. • European Union (EU) Regulations— conference, please visit the other legal and regulatory requirements jstallworth on DSK7TPTVN1PROD with NOTICES Exploring the Unknown. ‘‘Registration’’ link on the conference are met. • Impact of the New EU Regulations Web site at http:// FOR FURTHER INFORMATION CONTACT: on Your Global Regulatory Strategy. www.XavierMedCon.com. FDA has Anuj Shah, Center for Drug Evaluation • Digital Health—Key Focus Areas for verified the Web site address, but is not and Research, Food and Drug FDA and Industry. responsible for subsequent changes to Administration, 10903 New Hampshire • Office of Compliance Strategic the Web site after this document Ave., Bldg. 51, Rm. 6228, Silver Spring, Priorities. publishes in the Federal Register. MD 20993–0002, 301–796–2246. VerDate Sep<11>2014 15:11 Apr 04, 2017 Jkt 241001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\05APN1.SGM 05APN1

16600 Federal Register / Vol. 82, No. 64 / Wednesday, April 5, 2017 / Notices SUPPLEMENTARY INFORMATION: In 1984, bacterial otitis media; and S. pyogenes DEPARTMENT OF HEALTH AND Congress enacted the Drug Price in pharyngitis and tonsillitis. HUMAN SERVICES Competition and Patent Term CEDAX (ceftibuten dihydrate) for oral Restoration Act of 1984 (Pub. L. 98–417) suspension, 90 mg/5 mL and 180 mg/5 National Institutes of Health (the 1984 amendments), which mL, are currently listed in the authorized the approval of duplicate ‘‘Discontinued Drug Product List’’ National Institute of Biomedical versions of drug products under an section of the Orange Book. Imaging and Bioengineering; Notice of ANDA procedure. ANDA applicants Orchid Healthcare (a division of Meeting must, with certain exceptions, show that Orchid Pharma, Ltd.) submitted a Pursuant to section 10(d) of the the drug for which they are seeking citizen petition dated October 26, 2016 Federal Advisory Committee Act, as approval contains the same active (Docket No. FDA–2016–P–3560), under amended (5 U.S.C. App.), notice is ingredient in the same strength and 21 CFR 10.30, requesting that the hereby given of a meeting of the dosage form as the ‘‘listed drug,’’ which Agency determine whether CEDAX National Advisory Council for is a version of the drug that was (ceftibuten dihydrate) for oral Biomedical Imaging and Bioengineering. previously approved. ANDA applicants suspension, 90 mg/5 mL and 180 mg/5 The meeting will be open to the do not have to repeat the extensive mL, were withdrawn from sale for public as indicated below, with clinical testing otherwise necessary to reasons of safety or effectiveness. attendance limited to space available. gain approval of a new drug application After considering the citizen petition Individuals who plan to attend and (NDA). and reviewing Agency records and need special assistance, such as sign The 1984 amendments include what based on the information we have at this language interpretation or other is now section 505(j)(7) of the Federal time, FDA has determined under reasonable accommodations, should Food, Drug, and Cosmetic Act (21 U.S.C. § 314.161 that CEDAX (ceftibuten notify the Contact Person listed below 355(j)(7)), which requires FDA to dihydrate) for oral suspension, 90 mg/5 in advance of the meeting. publish a list of all approved drugs. mL and 180 mg/5 mL, were not The meeting will be closed to the FDA publishes this list as part of the withdrawn for reasons of safety or public in accordance with the ‘‘Approved Drug Products With effectiveness. The petitioner has provisions set forth in sections Therapeutic Equivalence Evaluations,’’ identified no data or other information 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., which is known generally as the suggesting that these drug products as amended. The grant applications ‘‘Orange Book.’’ Under FDA regulations, were withdrawn for reasons of safety or and/or contract proposals and the drugs are removed from the list if the effectiveness. We have carefully discussions could disclose confidential Agency withdraws or suspends reviewed our files for records trade secrets or commercial property approval of the drug’s NDA or ANDA concerning the withdrawal of CEDAX such as patentable material, and for reasons of safety or effectiveness or (ceftibuten dihydrate) for oral personal information concerning if FDA determines that the listed drug suspension, 90 mg/5 mL and 180 mg/5 individuals associated with the grant was withdrawn from sale for reasons of mL, from sale. We have also applications and/or contract proposals, safety or effectiveness (21 CFR 314.162). independently evaluated relevant the disclosure of which would A person may petition the Agency to literature and data for possible constitute a clearly unwarranted determine, or the Agency may postmarketing adverse events. We have invasion of personal privacy. determine on its own initiative, whether reviewed the available evidence and a listed drug was withdrawn from sale Name of Committee: National Advisory determined that these drug products for reasons of safety or effectiveness. Council for Biomedical Imaging and were not withdrawn from sale for Bioengineering. This determination may be made at any reasons of safety or effectiveness. Date: May 18, 2017. time after the drug has been withdrawn Accordingly, the Agency will Open: 8:30 a.m. to 12:00 p.m. from sale, but must be made prior to continue to list CEDAX (ceftibuten Agenda: Report from the Institute Director, approving an ANDA that refers to the dihydrate) for oral suspension, 90 mg/5 other Institute Staff and scientific listed drug (§ 314.161 (21 CFR 314.161)). mL and 180 mg/5 mL, in the presentation. FDA may not approve an ANDA that ‘‘Discontinued Drug Product List’’ Place: The William F. Bolger Center, does not refer to a listed drug. section of the Orange Book. The Franklin Building, Classroom 1, 9600 CEDAX (ceftibuten dihydrate) for oral Newbridge Drive, Potomac, MD 20854. ‘‘Discontinued Drug Product List’’ Closed: 1:00 p.m. to 4:00 p.m. suspension, 90 mg/5 mL and 180 mg/5 delineates, among other items, drug mL, are the subject of NDA 050686, held Agenda: To review and evaluate grant products that have been discontinued applications and/or proposals. by Pernix Therapeutics LLC, and from marketing for reasons other than Place: The William F. Bolger Center, initially approved on December 20, safety or effectiveness. ANDAs that refer Franklin Building, Classroom 1, 9600 1995. CEDAX is indicated for the to these drug products may be approved Newbridge Drive, Potomac, MD 20854. treatment of individuals with mild-to- by the Agency as long as they meet all Contact Person: David T. George, Ph.D., moderate infections caused by other legal and regulatory requirements Acting Associate Director, Office of Research susceptible strains of Haemophilus for the approval of ANDAs. If FDA Administration, National Institute of influenzae (including b-lactamase- Biomedical Imaging and Bioengineering, determines that labeling for these drug 6707 Democracy Boulevard, Room 920, producing strains), Moraxella products should be revised to meet Bethesda, MD 20892. catarrhalis (including b-lactamase- current standards, the Agency will producing strains), or Streptococcus Any interested person may file written advise ANDA applicants to submit such comments with the committee by forwarding pneumoniae (penicillin-susceptible jstallworth on DSK7TPTVN1PROD with NOTICES labeling. the statement to the Contact Person listed on strains only) in acute bacterial exacerbations of chronic bronchitis; H. Dated: March 30, 2017. this notice. The statement should include the Anna K. Abram, name, address, telephone number and when influenzae (including b-lactamase- applicable, the business or professional producing strains), M. catarrhalis Deputy Commissioner for Policy, Planning, affiliation of the interested person. (including b-lactamase-producing Legislation, and Analysis. Information is also available on the strains), or S. pneumoniae (penicillin- [FR Doc. 2017–06701 Filed 4–4–17; 8:45 am] Institute’s/Center’s home page: http:// susceptible strains only) in acute BILLING CODE 4164–01–P www.nibib1.nih.gov/about/NACBIB/ VerDate Sep<11>2014 15:11 Apr 04, 2017 Jkt 241001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\05APN1.SGM 05APN1


Document Created: 2018-02-01 14:47:12
Document Modified: 2018-02-01 14:47:12
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.
ContactAnuj 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.
FR Citation82 FR 16599 
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