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(Ceftibuten Dihydrate) for Oral Suspension, 90 Milligrams/5 Milliliters and 180 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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

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that CEDAX (ceftibuten dihydrate) for oral suspension, 90 milligrams (mg)/5 milliliters (mL) and 180 mg/5 mL, were not withdrawn from sale for reasons of safety or effectiveness.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, 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Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or 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milligrams (mg)/5 milliliters (mL) and 180 mg/5 mL, were not withdrawn 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