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[Federal Register Volume 87, Number 68 (Friday, April 8, 2022)]
[Notices]
[Pages 20875-20876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07563]

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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Milligram/Spray (50 Microgram), Was Not Withdrawn From Sale for Reasons 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.

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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milligram (mg)/spray (50 microgram (mcg)), was not withdrawn from sale 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, [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).

[[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:
     Treatment of nasal symptoms of allergic rhinitis in 
patients 2 years of age and older;
     treatment of nasal congestion associated with seasonal 
allergic rhinitis in patients 2 years of age or older;
     prophylaxis of seasonal allergic rhinitis in patients 12 
years of age or older; and
     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
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