Notice2021-11800
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That ATROVENT (Ipratropium Bromide) Metered Spray, 0.021 Micrograms/Spray and 0.042 Micrograms/Spray, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
June 7, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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that ATROVENT (ipratropium bromide) metered spray, 0.021 micrograms (mcg)/spray and 0.042 mcg/spray, were not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
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<title>Federal Register, Volume 86 Issue 107 (Monday, June 7, 2021)</title>
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[Federal Register Volume 86, Number 107 (Monday, June 7, 2021)]
[Notices]
[Pages 30321-30322]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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0.021 Micrograms/Spray and 0.042 Micrograms/Spray, Were Not Withdrawn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micrograms (mcg)/spray and 0.042 mcg/spray, were not withdrawn from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,
<a href="/cdn-cgi/l/email-protection#88dbfce9ebf1a6c3e9e6edc8eeece9a6e0e0fba6efe7fe"><span class="__cf_email__" data-cfemail="3f6c4b5e5c4611745e515a7f595b5e1157574c11585049">[email protected]</span></a>.
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
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