[Federal Register Volume 88, Number 213 (Monday, November 6, 2023)]
[Notices]
[Pages 76218-76219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24506]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-P-2536]


Determination That FORADIL (Formoterol Fumarate) Inhalation 
Powder, 0.012 Milligrams, Was Not Withdrawn From Sale for Reasons of 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, the Agency, or we) has 
determined that FORADIL (formoterol fumarate) inhalation powder, 0.012 
milligrams (mg)/inhalation (inh), was not withdrawn from sale for 
reasons of safety or effectiveness. This determination will allow FDA 
to approve abbreviated new drug applications (ANDAs) for formoterol 
fumarate inhalation powder, 0.012 mg/inh, if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Joe Thomas, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002, 202-815-5571, 
[email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of 
an ANDA to market a generic version of a previously approved drug 
product. To obtain approval, the ANDA applicant must show, among other 
things, that the generic drug product: (1) has the same active 
ingredient(s), dosage form, route of administration, strength, 
conditions of use, and (with certain exceptions) labeling as the listed 
drug, which is a version of the drug that was previously approved; and 
(2) is bioequivalent to the listed drug. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of 
all

[[Page 76219]]

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.
    FORADIL (formoterol fumarate) inhalation powder, 0.012 mg/inh, is 
the subject of NDA 020831, held by Novartis Pharmaceuticals Corp., and 
initially approved on February 16, 2001. FORADIL is indicated for 
treatment of asthma in patients 5 years of age and older as an add-on 
to a long-term asthma control medication such as an inhaled 
corticosteroid; prevention of exercise-induced bronchospasm (EIB) in 
patients 5 years of age and older; and maintenance treatment of 
bronchoconstriction in patients with chronic obstructive pulmonary 
disease.
    In a letter dated September 30, 2015, Novartis Pharmaceuticals 
Corp. notified FDA that FORADIL (formoterol fumarate) inhalation 
powder, 0.012 mg/inh, was being discontinued, and FDA moved the drug 
product to the ``Discontinued Drug Product List'' section of the Orange 
Book. In the Federal Register of June 21, 2018 (83 FR 28856), FDA 
announced that it was withdrawing approval of NDA 020831, effective 
July 23, 2018.
    K&L Gates LLP submitted a citizen petition dated June 21, 2023 
(Docket No. FDA-2023-P-2536), under 21 CFR 10.30, requesting that the 
Agency determine whether FORADIL (formoterol fumarate) inhalation 
powder, 0.012 mg/inh, was 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 FORADIL (formoterol fumarate) inhalation 
powder, 0.012 mg/inh, was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that FORADIL (formoterol fumarate) inhalation 
powder, 0.012 mg/inh, was withdrawn for reasons of safety or 
effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of FORADIL (formoterol fumarate) inhalation 
powder, 0.012 mg/inh, 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 this drug 
product was not withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list FORADIL (formoterol 
fumarate) inhalation powder, 0.012 mg/inh, 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. FDA will not begin procedures to withdraw approval of 
approved ANDAs that refer to this drug product. Additional ANDAs for 
this drug product may also 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 this drug product should be 
revised to meet current standards, the Agency will advise ANDA 
applicants to submit such labeling.

    Dated: November 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24506 Filed 11-3-23; 8:45 am]
BILLING CODE 4164-01-P