Notice2022-07563
Determination That NASONEX (Mometasone Furoate) Nasal Spray, 0.05 Milligram/Spray (50 Microgram), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 8, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that NASONEX (mometasone furoate) nasal spray, 0.05 milligram (mg)/spray (50 microgram (mcg)), was not withdrawn from sale for reasons of safety or effectiveness.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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 68 (Friday, April 8, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 68 (Friday, April 8, 2022)]
[Notices]
[Pages 20875-20876]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-07563]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-P-0077]
Determination That NASONEX (Mometasone Furoate) Nasal Spray, 0.05
Milligram/Spray (50 Microgram), Was Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has
determined that NASONEX (mometasone furoate) nasal spray, 0.05
milligram (mg)/spray (50 microgram (mcg)), was not withdrawn from sale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 this drug product, and it will
allow FDA to continue to approve ANDAs that refer to the product as
long as they meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Sungjoon Chi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6216, Silver Spring, MD 20993-0002, 240-
402-9674, <a href="/cdn-cgi/l/email-protection#1241677c75787d7d7c3c517a7b527476733c7a7a613c757d64"><span class="__cf_email__" data-cfemail="c596b0aba2afaaaaabeb86adac85a3a1a4ebadadb6eba2aab3">[email protected]</span></a>.
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).
[[Page 20876]]
Section 505(j)(7) of the FD&C Act 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.
NASONEX (mometasone furoate) nasal spray, 0.05 mg/spray 50 (mcg),
is the subject of NDA 020762, held by Organon LLC, and initially
approved on October 1, 1997. NASONEX (mometasone furoate) nasal spray,
0.05 mg/spray 50 (mcg) is a corticosteroid indicated for:
<bullet> Treatment of nasal symptoms of allergic rhinitis in
patients 2 years of age and older;
<bullet> treatment of nasal congestion associated with seasonal
allergic rhinitis in patients 2 years of age or older;
<bullet> prophylaxis of seasonal allergic rhinitis in patients 12
years of age or older; and
<bullet> treatment of nasal polyps in patients 18 years of age or
older.
In a letter dated December 4, 2020, Merck Sharp and Dohme Corp., a
subsidiary of Merck and Co., Inc., notified FDA that NASONEX
(mometasone furoate) nasal spray, 0.05 mg/spray 50 (mcg) was being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book.
Aurobindo Pharma Ltd. submitted a citizen petition dated January
14, 2022 (Docket No. FDA-2022-P-0077), under 21 CFR 10.30, requesting
that the Agency determine whether NASONEX (mometasone furoate) nasal
spray, 0.05 mg/spray 50 (mcg), 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 NASONEX (mometasone furoate) nasal spray, 0.05
mg/spray 50 (mcg) was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that NASONEX (mometasone furoate) nasal spray,
0.05 mg/spray 50 (mcg) was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of NASONEX (mometasone furoate) nasal spray,
0.05 mg/spray 50 (mcg) 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 this drug product
was withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list NASONEX (mometasone
furoate) nasal spray, 0.05 mg/spray 50 (mcg), 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: April 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07563 Filed 4-7-22; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on April 8, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.