[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Notices]
[Pages 12613-12614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04231]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-P-1725]


Determination That FLONASE (Fluticasone Propionate) Nasal Spray, 
0.05 Milligram, Was Not Withdrawn From Sale for Reasons of Safety or 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 or Agency) has 
determined that prescription FLONASE (fluticasone propionate) Nasal 
Spray, 0.05 milligram (mg), was not withdrawn from sale for reasons of 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 this 
determination will allow FDA to continue to approve ANDAs for 
fluticasone propionate nasal spray, 0.05 mg, if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: David Faranda, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 301-
796-8767.

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.
    Prescription FLONASE (fluticasone propionate) Nasal Spray, 0.05 mg, 
is the subject of NDA 020121, held by GlaxoSmithKline, and initially 
approved on October 19, 1994. FLONASE is indicated for the management 
of the nasal symptoms of perennial nonallergic rhinitis in adult and 
pediatric patients aged 4 years and older.
    In a letter dated May 25, 2016, GlaxoSmithKline notified FDA that 
prescription FLONASE (fluticasone propionate) Nasal Spray, 0.05 mg, was 
being discontinued, and FDA moved the drug product to the 
``Discontinued Drug Product List'' section of the Orange Book.
    Lachman Consultant Services, Inc., submitted a citizen petition 
dated June 20, 2016 (Docket No. FDA-2016-P-1725), under 21 CFR 10.30, 
requesting that the Agency determine whether prescription FLONASE 
(fluticasone propionate) Nasal Spray, 0.05 mg, 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 prescription FLONASE (fluticasone propionate) 
Nasal Spray, 0.05 mg, was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that this drug product was withdrawn for reasons 
of safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of prescription FLONASE (fluticasone 
propionate) Nasal Spray, 0.05 mg, from

[[Page 12614]]

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 prescription FLONASE 
(fluticasone propionate) Nasal Spray, 0.05 mg, 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. ANDAs that refer to prescription FLONASE (fluticasone 
propionate) Nasal Spray, 0.05 mg, may 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: February 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04231 Filed 3-3-17; 8:45 am]
 BILLING CODE 4164-01-P