81 FR 35362 - Determination That TRIVARIS (Triamcinolone Acetonide) Injectable Suspension, 80 Milligrams/Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 106 (June 2, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 106 (June 2, 2016)
| Page Range | 35362-35363 | |
| FR Document | 2016-12949 |
[Federal Register Volume 81, Number 106 (Thursday, June 2, 2016)] [Notices] [Pages 35362-35363] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-12949] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-P-0378] Determination That TRIVARIS (Triamcinolone Acetonide) Injectable Suspension, 80 Milligrams/Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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 [[Page 35363]] determined that TRIVARIS (triamcinolone acetonide) injectable suspension, 80 milligrams/milliliters (mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for triamcinolone acetonide injectable suspension, 80 mg/mL, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Linda Jong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6288, Silver Spring, MD 20993-0002, 301-796-3977. 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. TRIVARIS (triamcinolone acetonide) injectable suspension, 80 mg/mL, is the subject of NDA 22-220, held by Allergan, and initially approved on June 16, 2008. TRIVARIS is indicated for sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. TRIVARIS (triamcinolone acetonide) injectable suspension, 80 mg/mL, is currently listed in the ``Discontinued Drug Product List'' section of the Orange Book. The Weinberg Group submitted a citizen petition dated January 28, 2016 (Docket No. FDA-2016-P-0378), under 21 CFR 10.30, requesting that the Agency determine whether TRIVARIS (triamcinolone acetonide) injectable suspension, 80 mg/mL, 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 TRIVARIS (triamcinolone acetonide) injectable suspension, 80 mg/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that TRIVARIS (triamcinolone acetonide) injectable suspension, 80 mg/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of TRIVARIS (triamcinolone acetonide) injectable suspension, 80 mg/mL, 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 TRIVARIS (triamcinolone acetonide) injectable suspension, 80 mg/mL, 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 TRIVARIS (triamcinolone acetonide) injectable suspension, 80 mg/mL, 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: May 27, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-12949 Filed 6-1-16; 8:45 am] BILLING CODE 4164-01-P
![35362 Federal Register / Vol. 81, No. 106 / Thursday, June 2, 2016 / Notices
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AGENCY: Food and Drug Administration, • FDA Inspections: Challenges and
HHS. Opportunities (Working Luncheon) Dated: May 26, 2016.
ACTION: Notice of conference. • Drug Shortages Leslie Kux,
• Drug Supply Chain Act: Wholesale Associate Commissioner for Policy.
SUMMARY: The Food and Drug Drug Distributor and 3rd Party [FR Doc. 2016–12942 Filed 6–1–16; 8:45 am]
Administration (FDA) Philadelphia Logistics Provider BILLING CODE 4164–01–P
District Office, in co-sponsorship with • Medical Device Single Audit Program
the Association of Food and Drug • Compliance Questions Panel
Officials (AFDO), and the North Central The Conference Web site is: http:// DEPARTMENT OF HEALTH AND
Association of Food and Drug Officials, afdo.org/conference. The meeting times HUMAN SERVICES
is announcing a conference entitled are as follows:
‘‘Collaborating to Strengthen Food, Food and Drug Administration
Drug, and Medical Device Safety Date Meeting time [Docket No. FDA–2016–P–0378]
Systems.’’ This conference is intended
to provide information about FDA drug June 25 ....... 8 a.m. to 5 p.m. Determination That TRIVARIS
and device regulation to the regulated June 26 ....... 8 a.m. to 6 p.m. (Triamcinolone Acetonide) Injectable
industry. June 27 ....... 8 a.m. to 5:30 p.m.
Suspension, 80 Milligrams/Milliliters,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
June 28 ....... 8 a.m. to 5 p.m.
DATES: The conference will be held on June 29 ....... 8 a.m. to 11:30 a.m. Was Not Withdrawn From Sale for
June 25 to June 29, 2016. See Reasons of Safety or Effectiveness
SUPPLEMENTARY INFORMATION for meeting Registration: The AFDO registration AGENCY: Food and Drug Administration,
times. fees cover the cost of facilities, HHS.
ADDRESSES: The Omni William Penn materials, and breaks. Seats are limited ACTION: Notice.
Hotel, 530 William Penn Pl., Pittsburgh, and registration will close after the
PA 15219. Attendees are responsible for course is filled; therefore, please submit SUMMARY: The Food and Drug
their own accommodations. your registration as soon as possible. Administration (FDA or Agency) has
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![Federal Register / Vol. 81, No. 106 / Thursday, June 2, 2016 / Notices 35363
determined that TRIVARIS Allergan, and initially approved on June Dated: May 27, 2016.
(triamcinolone acetonide) injectable 16, 2008. TRIVARIS is indicated for Leslie Kux,
suspension, 80 milligrams/milliliters sympathetic ophthalmia, temporal Associate Commissioner for Policy.
(mg/mL), was not withdrawn from sale arteritis, uveitis, and ocular [FR Doc. 2016–12949 Filed 6–1–16; 8:45 am]
for reasons of safety or effectiveness. inflammatory conditions unresponsive BILLING CODE 4164–01–P
This determination will allow FDA to to topical corticosteroids. TRIVARIS
approve abbreviated new drug (triamcinolone acetonide) injectable
applications (ANDAs) for triamcinolone suspension, 80 mg/mL, is currently DEPARTMENT OF HEALTH AND
acetonide injectable suspension, 80 mg/ listed in the ‘‘Discontinued Drug HUMAN SERVICES
mL, if all other legal and regulatory Product List’’ section of the Orange
requirements are met. Food and Drug Administration
Book.
FOR FURTHER INFORMATION CONTACT: [Docket No. FDA–2014–D–0055]
Linda Jong, Center for Drug Evaluation The Weinberg Group submitted a
and Research, Food and Drug citizen petition dated January 28, 2016 Voluntary Sodium Reduction Goals:
Administration, 10903 New Hampshire (Docket No. FDA–2016–P–0378), under Target Mean and Upper Bound
Ave., Bldg. 51, Rm. 6288, Silver Spring, 21 CFR 10.30, requesting that the Concentrations for Sodium in
MD 20993–0002, 301–796–3977. Agency determine whether TRIVARIS Commercially Processed, Packaged,
SUPPLEMENTARY INFORMATION: In 1984,
(triamcinolone acetonide) injectable and Prepared Foods; Draft Guidance
Congress enacted the Drug Price suspension, 80 mg/mL, was withdrawn for Industry; Availability
Competition and Patent Term from sale for reasons of safety or
AGENCY: Food and Drug Administration,
Restoration Act of 1984 (Pub. L. 98–417) effectiveness.
HHS.
(the 1984 amendments), which After considering the citizen petition ACTION: Notice of availability.
authorized the approval of duplicate and reviewing Agency records and
versions of drug products under an based on the information we have at this SUMMARY: The Food and Drug
ANDA procedure. ANDA applicants time, FDA has determined under Administration (FDA or we) is
must, with certain exceptions, show that § 314.161 that TRIVARIS (triamcinolone announcing the availability of a draft
the drug for which they are seeking acetonide) injectable suspension, 80 mg/ guidance entitled ‘‘Voluntary Sodium
approval contains the same active mL, was not withdrawn for reasons of Reduction Goals: Target Mean and
ingredient in the same strength and safety or effectiveness. The petitioner Upper Bound Concentrations for
dosage form as the ‘‘listed drug,’’ which has identified no data or other Sodium in Commercially Processed,
is a version of the drug that was Packaged, and Prepared Foods.’’ The
information suggesting that TRIVARIS
previously approved. ANDA applicants draft guidance, when finalized, will
(triamcinolone acetonide) injectable
do not have to repeat the extensive describe our views on voluntary short-
suspension, 80 mg/mL, was withdrawn term and long-term goals for sodium
clinical testing otherwise necessary to
for reasons of safety or effectiveness. We reduction in a variety of identified
gain approval of a new drug application
(NDA). have carefully reviewed our files for categories of foods that are
The 1984 amendments include what records concerning the withdrawal of commercially processed, packaged, or
is now section 505(j)(7) of the Federal TRIVARIS (triamcinolone acetonide) prepared. These goals are intended to
Food, Drug, and Cosmetic Act (21 U.S.C. injectable suspension, 80 mg/mL, from address the excessive intake of sodium
355(j)(7)), which requires FDA to sale. We have also independently in the current population and promote
publish a list of all approved drugs. evaluated relevant literature and data improvements in public health.
FDA publishes this list as part of the for possible postmarketing adverse DATES: Although you can comment on
‘‘Approved Drug Products With events. We have found no information any guidance at any time (see 21 CFR
Therapeutic Equivalence Evaluations,’’ that would indicate that this drug 10.115(g)(5)), to ensure that the Agency
which is known generally as the product was withdrawn from sale for considers your comment on the draft
‘‘Orange Book.’’ Under FDA regulations, reasons of safety or effectiveness. guidance before it begins work on the
drugs are removed from the list if the Accordingly, the Agency will final version of the guidance, submit
Agency withdraws or suspends continue to list TRIVARIS either electronic or written comments
approval of the drug’s NDA or ANDA (triamcinolone acetonide) injectable on Issues 1 through 4 listed in section
for reasons of safety or effectiveness or suspension, 80 mg/mL, in the IV of this document by August 31, 2016.
if FDA determines that the listed drug ‘‘Discontinued Drug Product List’’ Submit either electronic or written
was withdrawn from sale for reasons of comments on Issues 5 through 8 listed
section of the Orange Book. The
safety or effectiveness (21 CFR 314.162). in section IV of this document by
‘‘Discontinued Drug Product List’’
A person may petition the Agency to October 31, 2016.
determine, or the Agency may delineates, among other items, drug
products that have been discontinued ADDRESSES: You may submit comments
determine on its own initiative, whether as follows:
a listed drug was withdrawn from sale from marketing for reasons other than
for reasons of safety or effectiveness. safety or effectiveness. ANDAs that refer Electronic Submissions
This determination may be made at any to TRIVARIS (triamcinolone acetonide) Submit electronic comments in the
time after the drug has been withdrawn injectable suspension, 80 mg/mL, may following way:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
from sale, but must be made prior to be approved by the Agency as long as • Federal eRulemaking Portal: http://
approving an ANDA that refers to the they meet all other legal and regulatory www.regulations.gov. Follow the
listed drug (§ 314.161 (21 CFR 314.161)). requirements for the approval of instructions for submitting comments.
FDA may not approve an ANDA that ANDAs. If FDA determines that labeling Comments submitted electronically,
does not refer to a listed drug. for this drug product should be revised including attachments, to http://
TRIVARIS (triamcinolone acetonide) to meet current standards, the Agency www.regulations.gov will be posted to
injectable suspension, 80 mg/mL, is the will advise ANDA applicants to submit the docket unchanged. Because your
subject of NDA 22–220, held by such labeling. comment will be made public, you are
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Document Created: 2016-06-02 01:23:02
Document Modified: 2016-06-02 01:23:02
| 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 | Linda Jong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6288, Silver Spring, MD 20993-0002, 301-796-3977. | |
| FR Citation | 81 FR 35362 |
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