[Federal Register Volume 86, Number 107 (Monday, June 7, 2021)]
[Notices]
[Pages 30321-30322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11800]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-P-2174]


Determination That ATROVENT (Ipratropium Bromide) Metered Spray, 
0.021 Micrograms/Spray and 0.042 Micrograms/Spray, Were Not Withdrawn 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 ATROVENT (ipratropium bromide) metered spray, 0.021 
micrograms (mcg)/spray and 0.042 mcg/spray, were not withdrawn from 
sale for reasons of safety or effectiveness. This determination means 
that FDA will not begin procedures to withdraw approval of abbreviated 
new drug applications (ANDAs) that refer to these drug products, and it 
will allow FDA to continue to approve ANDAs that refer to the products 
as long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, 
[email protected].

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.
    ATROVENT (ipratropium bromide) metered spray, 0.021 mcg/spray, is 
the subject of NDA 020393 and ATROVENT (ipratropium bromide) metered 
spray, 0.042 mcg/spray, is the subject of NDA 020394, both held by 
Boehringer Ingelheim Pharmaceuticals, Inc., and initially approved on 
October 20, 1995. ATROVENT is indicated for the symptomatic relief of 
rhinorrhea associated with allergic and nonallergic perennial rhinitis 
in adults and children age 6 years and older.
    In letters dated December 22, 2017, Boehringer Ingelheim 
Pharmaceuticals, Inc., requested withdrawal of NDA 020393 and NDA 
020394 for ATROVENT (ipratropium bromide). In the Federal Register of 
July 12, 2018 (83 FR 32305), FDA announced that it was withdrawing 
approval of NDA 020393 and NDA 020394, effective August 13, 2018.
    Lachman Consulting Services, Inc., submitted a citizen petition 
dated November 5, 2020 (Docket No. FDA-2020-P-2174), under 21 CFR 
10.30, requesting that the Agency determine whether ATROVENT 
(ipratropium bromide) metered spray, 0.021 mcg/spray and 0.042 mcg/
spray, 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 ATROVENT (ipratropium bromide) metered spray, 
0.021 mcg/spray and 0.042 mcg/spray, were not withdrawn for reasons of 
safety or effectiveness. The petitioner has identified no data or other 
information suggesting that ATROVENT (ipratropium bromide) metered 
spray, 0.021 mcg/spray and 0.042 mcg/spray, were withdrawn for reasons 
of safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of ATROVENT (ipratropium bromide) 
metered spray, 0.021 mcg/spray and 0.042 mcg/spray, from sale. We have 
also independently evaluated relevant literature and data for possible 
postmarketing adverse events. We have found no information that would 
indicate that these drug products were withdrawn from sale for reasons 
of safety or effectiveness.
    Accordingly, the Agency will continue to list ATROVENT (ipratropium 
bromide) metered spray, 0.021 mcg/spray and 0.042 mcg/spray, in the 
``Discontinued Drug Product List'' section of the Orange Book. The 
``Discontinued Drug Product List''

[[Page 30322]]

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 these drug products. 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 these drug products should be revised 
to meet current standards, the Agency will advise ANDA applicants to 
submit such labeling.

    Dated: May 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11800 Filed 6-4-21; 8:45 am]
BILLING CODE 4164-01-P