82 FR 12613 - Determination That FLONASE (Fluticasone Propionate) Nasal Spray, 0.05 Milligram, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 42 (March 6, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 42 (March 6, 2017)
| Page Range | 12613-12614 | |
| FR Document | 2017-04231 |
[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)] [Notices] [Pages 12613-12614] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-04231] ----------------------------------------------------------------------- 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[Docket No. FDA-2016-P-1725] Determination That FLONASE (Fluticasone Propionate) Nasal Spray, 0.05 Milligram, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- 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or Agency) has determined that prescription FLONASE (fluticasone propionate) Nasal Spray, 0.05 milligram (mg), was not withdrawn from sale for reasons of safety or effectiveness.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
![Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices 12613
(b) How do you/your child weigh the Dated February 28, 2017. 355(j)(7)), which requires FDA to
potential benefits of these treatments Leslie Kux, publish a list of all approved drugs.
versus the common side effects of the Associate Commissioner for Policy. FDA publishes this list as part of the
treatments? (Common side effects could [FR Doc. 2017–04229 Filed 3–3–17; 8:45 am] ‘‘Approved Drug Products With
include headache, nausea, fatigue, BILLING CODE 4164–01–P
Therapeutic Equivalence Evaluations,’’
weight gain) which is known generally as the
(c) How do you/your child weigh ‘‘Orange Book.’’ Under FDA regulations,
potential benefits of these treatments DEPARTMENT OF HEALTH AND drugs are removed from the list if the
versus the less common but serious HUMAN SERVICES Agency withdraws or suspends
risks associated with the treatments? approval of the drug’s NDA or ANDA
(Examples of less common but serious Food and Drug Administration for reasons of safety or effectiveness, or
risks are infections, organ damage or if FDA determines that the listed drug
failure, suicidal thoughts) [Docket No. FDA–2016–P–1725]
was withdrawn from sale for reasons of
III. Meeting Attendance and Determination That FLONASE safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
Participation (Fluticasone Propionate) Nasal Spray,
determine, or the Agency may
If you wish to attend this meeting, 0.05 Milligram, Was Not Withdrawn
determine on its own initiative, whether
visit https://autismpfdd.eventbrite.com. From Sale for Reasons of Safety or
a listed drug was withdrawn from sale
Persons interested in attending this Effectiveness
for reasons of safety or effectiveness.
public meeting must register by April AGENCY: Food and Drug Administration, This determination may be made at any
24, 2017. If you are unable to attend the HHS. time after the drug has been withdrawn
meeting in person, you can register to from sale, but must be made prior to
ACTION: Notice.
view a live Webcast of the meeting. You approving an ANDA that refers to the
will be asked to indicate in your SUMMARY: The Food and Drug listed drug (§ 314.161 (21 CFR 314.161)).
registration if you plan to attend in Administration (FDA or Agency) has FDA may not approve an ANDA that
person or via the Webcast. Registration determined that prescription FLONASE does not refer to a listed drug.
is free and based on space availability, (fluticasone propionate) Nasal Spray, Prescription FLONASE (fluticasone
with priority given to early registrants. 0.05 milligram (mg), was not withdrawn propionate) Nasal Spray, 0.05 mg, is the
Early registration is recommended from sale for reasons of safety or subject of NDA 020121, held by
because seating is limited; therefore, effectiveness. This determination means GlaxoSmithKline, and initially
FDA may limit the number of that FDA will not begin procedures to approved on October 19, 1994.
participants from each organization. withdraw approval of abbreviated new FLONASE is indicated for the
Registrants will receive confirmation drug applications (ANDAs) that refer to management of the nasal symptoms of
once they have been accepted. Onsite this drug product, and this perennial nonallergic rhinitis in adult
registration on the day of the meeting determination will allow FDA to and pediatric patients aged 4 years and
will be based on space availability. If continue to approve ANDAs for older.
you need special accommodations fluticasone propionate nasal spray, 0.05 In a letter dated May 25, 2016,
because of a disability, please contact mg, if all other legal and regulatory GlaxoSmithKline notified FDA that
Shanon Woodward (see FOR FURTHER requirements are met. prescription FLONASE (fluticasone
INFORMATION CONTACT) at least 7 days propionate) Nasal Spray, 0.05 mg, was
before the meeting. FOR FURTHER INFORMATION CONTACT:
being discontinued, and FDA moved the
Patients and patient representatives David Faranda, Center for Drug drug product to the ‘‘Discontinued Drug
who are interested in presenting Evaluation and Research, Food and Product List’’ section of the Orange
comments as part of the initial panel Drug Administration, 10903 New Book.
discussions will be asked to indicate in Hampshire Ave., Bldg. 51, Rm. 6208, Lachman Consultant Services, Inc.,
their registration which topic(s) they Silver Spring, MD 20993–0002, 301– submitted a citizen petition dated June
wish to address. These patients and 796–8767. 20, 2016 (Docket No. FDA–2016–P–
patient representatives also must send SUPPLEMENTARY INFORMATION: In 1984, 1725), under 21 CFR 10.30, requesting
to PatientFocused@fda.hhs.gov a brief Congress enacted the Drug Price that the Agency determine whether
summary of responses to the topic Competition and Patent Term prescription FLONASE (fluticasone
questions by April 17, 2017. Panelists Restoration Act of 1984 (Pub. L. 98–417) propionate) Nasal Spray, 0.05 mg, was
will be notified of their selection (the 1984 amendments), which withdrawn from sale for reasons of
approximately 7 days before the public authorized the approval of duplicate safety or effectiveness.
meeting. We will try to accommodate all versions of drug products under an After considering the citizen petition
patients and patient representatives who ANDA procedure. ANDA applicants and reviewing Agency records and
wish to speak, either through the panel must, with certain exceptions, show that based on the information we have at this
discussion or audience participation; the drug for which they are seeking time, FDA has determined under
however, the duration of comments may approval contains the same active § 314.161 that prescription FLONASE
be limited by time constraints. ingredient in the same strength and (fluticasone propionate) Nasal Spray,
Transcripts: Please be advised that as dosage form as the ‘‘listed drug,’’ which 0.05 mg, was not withdrawn for reasons
soon as a transcript is available, it will is a version of the drug that was of safety or effectiveness. The petitioner
asabaliauskas on DSK3SPTVN1PROD with NOTICES
be accessible at https:// previously approved. ANDA applicants has identified no data or other
www.regulations.gov. It may be viewed do not have to repeat the extensive information suggesting that this drug
at the Division of Dockets Management clinical testing otherwise necessary to product was withdrawn for reasons of
(see ADDRESSES). A link to the transcript gain approval of a new drug application safety or effectiveness. We have
will also be available on the Internet at (NDA). carefully reviewed our files for records
http://www.fda.gov/ForIndustry/ The 1984 amendments include what concerning the withdrawal of
UserFees/PrescriptionDrugUserFee/ is now section 505(j)(7) of the Federal prescription FLONASE (fluticasone
ucm529043.htm. Food, Drug, and Cosmetic Act (21 U.S.C. propionate) Nasal Spray, 0.05 mg, from
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![12614 Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices
sale. We have also independently Administration, 10903 New Hampshire FOR FURTHER INFORMATION CONTACT:
evaluated relevant literature and data Ave., Silver Spring, MD 20993–0002, Designated Federal Officer, 2018
for possible postmarketing adverse 301–796–4842, FAX: 301–796–9858, Physical Activity Guidelines Advisory
events. We have found no information email: larry.bauer@fda.hhs.gov. Committee, Richard D. Olson, M.D.,
that would indicate that this drug SUPPLEMENTARY INFORMATION: FDA is M.P.H. and/or Alternate Designated
product was withdrawn from sale for announcing the issuance of a priority Federal Officer, Katrina L. Piercy, Ph.D.,
reasons of safety or effectiveness. review voucher to the sponsor of a rare R.D., Office of Disease Prevention and
Accordingly, the Agency will pediatric disease product application. Health Promotion (ODPHP), Office of
continue to list prescription FLONASE Under section 529 of the FD&C Act (21 the Assistant Secretary for Health
(fluticasone propionate) Nasal Spray, U.S.C. 360ff), which was added by (OASH), HHS; 1101 Wootton Parkway,
0.05 mg, in the ‘‘Discontinued Drug FDASIA, FDA will award priority Suite LL–100; Rockville, MD 20852;
Product List’’ section of the Orange review vouchers to sponsors of rare Telephone: (240) 453–8280. Additional
Book. The ‘‘Discontinued Drug Product pediatric disease product applications information is available at
List’’ delineates, among other items, that meet certain criteria. FDA has www.health.gov/paguidelines.
drug products that have been determined that SPINRAZA SUPPLEMENTARY INFORMATION: The
discontinued from marketing for reasons (nusinersen), manufactured by Biogen inaugural Physical Activity Guidelines
other than safety or effectiveness. Inc., meets the criteria for a priority for Americans (PAG), issued in 2008,
ANDAs that refer to prescription review voucher. SPINRAZA represents the first comprehensive
FLONASE (fluticasone propionate) (nusinersen) is indicated for the guidelines on physical activity issued
Nasal Spray, 0.05 mg, may be approved treatment of spinal muscular atrophy in by the federal government. The PAG
by the Agency as long as they meet all pediatric and adult patients. serves as the benchmark and primary,
other legal and regulatory requirements For further information about the Rare authoritative voice of the federal
for the approval of ANDAs. If FDA Pediatric Disease Priority Review government for providing science-based
determines that labeling for this drug Voucher Program and for a link to the guidance on physical activity, fitness,
product should be revised to meet full text of section 529 of the FD&C Act, and health for Americans. Five years
current standards, the Agency will go to http://www.fda.gov/ForIndustry/ after the first edition was released,
advise ANDA applicants to submit such DevelopingProductsforRareDiseases ODPHP, in collaboration with the
labeling. Conditions/RarePediatricDiseasePriority Centers for Disease Control and
Dated: February 28, 2017. VoucherProgram/default.htm. For Prevention (CDC), the National
Leslie Kux, further information about SPINRAZA Institutes of Health (NIH), and the
Associate Commissioner for Policy. (nusinersen), go to the ‘‘Drugs@FDA’’ President’s Council on Fitness, Sports,
[FR Doc. 2017–04231 Filed 3–3–17; 8:45 am] Web site at http://www.accessdata.fda. and Nutrition (PCFSN) led development
gov/scripts/cder/daf/. of the PAG Midcourse Report: Strategies
BILLING CODE 4164–01–P
to Increase Physical Activity Among
Dated: February 28, 2017.
Youth. The second edition of the PAG
Leslie Kux, will build upon the first edition and
DEPARTMENT OF HEALTH AND Associate Commissioner for Policy.
HUMAN SERVICES provide a foundation for federal
[FR Doc. 2017–04228 Filed 3–3–17; 8:45 am] recommendations and education for
Food and Drug Administration BILLING CODE 4164–01–P physical activity programs for
Americans, including those at risk for
[Docket No. FDA–2017–N–0809]
chronic disease.
DEPARTMENT OF HEALTH AND Appointed Committee Members: The
Issuance of Priority Review Voucher; HUMAN SERVICES
Rare Pediatric Disease Product Secretary of HHS appointed 17
individuals to serve as members of the
AGENCY: Food and Drug Administration, Meeting of the 2018 Physical Activity 2018 PAGAC in June 2016. Information
HHS. Guidelines Advisory Committee on Committee membership is available
ACTION: Notice. AGENCY: U.S. Department of Health and at www.health.gov/paguidelines/second-
Human Services, Office of the Secretary, edition/committee/.
SUMMARY: The Food and Drug Office of the Assistant Secretary for Committee’s Task: The work of the
Administration (FDA) is announcing the Health, Office of Disease Prevention and 2018 PAGAC will be time-limited and
issuance of a priority review voucher to Health Promotion. solely advisory in nature. The
the sponsor of a rare pediatric disease Committee will develop
product application. The Federal Food, ACTION: Notice.
recommendations based on the
Drug, and Cosmetic Act (FD&C Act), as preponderance of current scientific and
amended by the Food and Drug SUMMARY: As stipulated by the Federal
Advisory Committee Act (FACA), the medical knowledge using a systematic
Administration Safety and Innovation review approach. The Committee will
Act (FDASIA), authorizes FDA to award U.S. Department of Health and Human
Services (HHS) is hereby giving notice examine the current PAG, take into
priority review vouchers to sponsors of consideration new scientific evidence
rare pediatric disease product that the third meeting of the 2018
Physical Activity Guidelines Advisory and current resource documents, and
applications that meet certain criteria. develop a scientific report to the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
FDA has determined that SPINRAZA Committee (2018 PAGAC or Committee)
will be held. This meeting will be open Secretary of HHS that outlines its
(nusinersen), manufactured by Biogen science-based advice and
Inc., meets the criteria for a priority to the public via videocast.
recommendations for development of
review voucher. DATES: The meeting will be held on the second edition of the PAG. The
FOR FURTHER INFORMATION CONTACT: March 23, 2017, from 8:00 a.m. E.T. to Committee will hold approximately five
Larry Bauer, Rare Diseases Program, 5:30 p.m. E.T. public meetings to review and discuss
Center for Drug Evaluation and ADDRESSES: The meeting will be recommendations. The first meeting was
Research, Food and Drug accessible by videocast on the Internet. held in July 2016 and the second in
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Document Created: 2017-03-04 00:07:07
Document Modified: 2017-03-04 00:07:07
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 82 FR 12613 |
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