81 FR 13797 - Determination That KENALOG (Triamcinolone Acetonide) Lotion and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 50 (March 15, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 50 (March 15, 2016)
| Page Range | 13797-13798 | |
| FR Document | 2016-05717 |
[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)] [Notices] [Pages 13797-13798] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05717] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0819] Determination That KENALOG (Triamcinolone Acetonide) Lotion and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363, [email protected]. 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 approved 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 generally known as the ``Orange Book.'' Under FDA regulations, a drug is 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). Under Sec. 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the table in this document are no longer being marketed. [[Page 13798]] -------------------------------------------------------------------------------------------------------------------------------------------------------- Application No. Drug Name Active Ingredient(s) Strength(s) Dosage Form/Route Applicant -------------------------------------------------------------------------------------------------------------------------------------------------------- NDA 011602......................... KENALOG............... Triamcinolone 0.025%; 0.1%......... Lotion; Topical...... Delcor Asset Corp. Acetonide. NDA 016059......................... INDOCIN............... Indomethacin.......... 25 milligrams (mg); Capsule; Oral........ Iroko 50 mg. Pharmaceuticals, LLC. NDA 017560......................... BACTRIM and BACTRIM Sulfamethoxazole; 200 mg/5 milliliters Suspension; Oral..... Mutual Pharmaceutical PEDIATRIC. Trimethoprim. (mL); 40 mg/5 mL. Company, Inc. NDA 017598......................... SEPTRA and SEPTRA Sulfamethoxazole; 200 mg/5 mL; 40 mg/5 Suspension; Oral..... Monarch GRAPE. Trimethoprim. mL. Pharmaceuticals, Inc. NDA 018185......................... INDOCIN SR............ Indomethacin.......... 75 mg................ Extended-Release Iroko Capsule; Oral. Pharmaceuticals, LLC. NDA 018450......................... NITROPRESS............ Sodium Nitroprusside.. 50 mg/vial........... Injectable; Injection AbbVie Inc. NDA 019834......................... PLENDIL............... Felodipine............ 2.5 mg; 5 mg; 10 mg.. Extended-Release AstraZeneca. Tablet; Oral. NDA 021475......................... METHYLIN.............. Methylphenidate 2.5 mg; 5 mg; 10 mg.. Chewable Tablet; Oral Mallinckrodt Hydrochloride. Pharmaceuticals. NDA 050320......................... UNIPEN................ Nafcillin Sodium...... Equal to (EQ) 500 mg Injectable; Injection Wyeth Ayerst base/vial; EQ 1 g Pharmaceuticals. (gram) base/vial; EQ 2 g base/vial; EQ 4 g base/vial; EQ 10 g base/vial; EQ 20 g base/vial. NDA 050406......................... KEFLEX................ Cephalexin............ EQ 125 mg base/5 mL; For Suspension; Oral. Shionogi Inc. EQ 250 mg base/5 mL; EQ 100 mg base/mL. ANDA 060576........................ MYCOLOG-II............ Nystatin; 100,000 units/g; 0.1% Cream; Topical....... Delcor Asset Corp. Triamcinolone Acetonide. ANDA 062117........................ CEPHALEXIN............ Cephalexin............ EQ 125 mg base/5 mL; For suspension; Oral. Facta Farmaceutici EQ 250 mg base/5 mL; S.p.A. EQ 100 mg base/mL. ANDA 062606........................ MYCOLOG-II............ Nystatin; 100,000 units/g; 0.1% Cream; Topical....... Delcor Asset Corp. Triamcinolone Acetonide. ANDA 062717........................ UNIPEN................ Nafcillin Sodium...... EQ 500 mg base/vial; Injectable; Injection Wyeth Ayerst EQ 1 g base/vial; EQ Pharmaceuticals. 2 g base/vial. -------------------------------------------------------------------------------------------------------------------------------------------------------- FDA has reviewed its records and, under Sec. 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the ``Discontinued Drug Product List'' section of the Orange Book. The ``Discontinued Drug Product List'' identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the NDAs and ANDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: March 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-05717 Filed 3-14-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices 13797
management of acute pain. The product meeting will be closed to permit meet relevant legal and regulatory
has been formulated with the intent to discussion and review of trade secret requirements.
provide abuse-deterrent properties. and/or confidential commercial
FOR FURTHER INFORMATION CONTACT:
Benzhydrocodone is a hydrocodone information (5 U.S.C. 552b(c)(4)).
prodrug which, according to the Stacy Kane, Center for Drug Evaluation
During this session, the committees will
applicant, is rapidly converted into and Research, Food and Drug
discuss the drug development program
hydrocodone by enzymes in the Administration, 10903 New Hampshire
of an investigational abuse-deterrent
gastrointestinal tract. The active drugs Ave., Bldg. 51, Rm. 6207, Silver Spring,
opioid product.
in this fixed-dose combination are MD 20993–0002, 301–796–8363,
Persons attending FDA’s advisory
hydrocodone and acetaminophen. The Stacy.Kane@fda.hhs.gov.
committee meetings are advised that the
applicant has submitted data to support Agency is not responsible for providing SUPPLEMENTARY INFORMATION: In 1984,
abuse-deterrent properties for this access to electrical outlets. Congress enacted the Drug Price
product. The committees will be asked FDA welcomes the attendance of the Competition and Patent Term
to discuss whether the applicant has public at its advisory committee Restoration Act of 1984 (Pub. L. 98–417)
demonstrated abuse-deterrent properties meetings and will make every effort to (the 1984 amendments), which
for their product that would support accommodate persons with disabilities. authorized the approval of duplicate
labeling, and whether the nasal route of If you require accommodations due to a versions of drug products approved
abuse is relevant for combination disability, please contact Stephanie L. under an ANDA procedure. ANDA
products made up of hydrocodone and Begansky at least 7 days in advance of applicants must, with certain
acetaminophen. the meeting. exceptions, show that the drug for
FDA intends to make background FDA is committed to the orderly which they are seeking approval
material available to the public no later conduct of its advisory committee contains the same active ingredient in
than 2 business days before the meeting. meetings. Please visit our Web site at the same strength and dosage form as
If FDA is unable to post the background http://www.fda.gov/ the ‘‘listed drug,’’ which is a version of
material on its Web site prior to the AdvisoryCommittees/ the drug that was previously approved.
meeting, the background material will AboutAdvisoryCommittees/ ANDA applicants do not have to repeat
be made publicly available at the ucm111462.htm for procedures on the extensive clinical testing otherwise
location of the advisory committee public conduct during advisory necessary to gain approval of a new
meeting, and the background material committee meetings. drug application (NDA).
will be posted on FDA’s Web site after Notice of this meeting is given under The 1984 amendments include what
the meeting. Background material is the Federal Advisory Committee Act (5 is now section 505(j)(7) of the Federal
available at http://www.fda.gov/ U.S.C. app. 2). Food, Drug, and Cosmetic Act (21 U.S.C.
AdvisoryCommittees/Calendar/ 355(j)(7)), which requires FDA to
default.htm. Scroll down to the Dated: March 9, 2016.
Jill Hartzler Warner,
publish a list of all approved drugs.
appropriate advisory committee meeting FDA publishes this list as part of the
link. Associate Commissioner for Special Medical
Programs.
‘‘Approved Drug Products With
Procedure: On May 5, 2016, from 9:15
Therapeutic Equivalence Evaluations,’’
a.m. to 5 p.m., the meeting is open to [FR Doc. 2016–05748 Filed 3–14–16; 8:45 am]
which is generally known as the
the public. Interested persons may BILLING CODE 4164–01–P
‘‘Orange Book.’’ Under FDA regulations,
present data, information, or views,
a drug is removed from the list if the
orally or in writing, on issues pending
Agency withdraws or suspends
before the committee. Written DEPARTMENT OF HEALTH AND
approval of the drug’s NDA or ANDA
submissions may be made to the contact HUMAN SERVICES
person on or before April 21, 2016. Oral for reasons of safety or effectiveness, or
presentations from the public will be Food and Drug Administration if FDA determines that the listed drug
scheduled between approximately 1:30 was withdrawn from sale for reasons of
p.m. and 2:30 p.m. Those individuals
[Docket No. FDA–2016–N–0819] safety or effectiveness (21 CFR 314.162).
interested in making formal oral Under § 314.161(a) (21 CFR
Determination That KENALOG 314.161(a)), the Agency must determine
presentations should notify the contact (Triamcinolone Acetonide) Lotion and
person and submit a brief statement of whether a listed drug was withdrawn
Other Drug Products Were Not from sale for reasons of safety or
the general nature of the evidence or Withdrawn From Sale for Reasons of
arguments they wish to present, the effectiveness: (1) Before an ANDA that
Safety or Effectiveness refers to that listed drug may be
names and addresses of proposed
participants, and an indication of the AGENCY: Food and Drug Administration, approved, (2) whenever a listed drug is
approximate time requested to make HHS. voluntarily withdrawn from sale and
their presentation on or before April 13, ACTION: Notice. ANDAs that refer to the listed drug have
2016. Time allotted for each been approved, and (3) when a person
presentation may be limited. If the SUMMARY: The Food and Drug petitions for such a determination under
number of registrants requesting to Administration (FDA or Agency) has 21 CFR 10.25(a) and 10.30. Section
speak is greater than can be reasonably determined that the drug products listed 314.161(d) provides that if FDA
in this document were not withdrawn determines that a listed drug was
asabaliauskas on DSK3SPTVN1PROD with NOTICES
accommodated during the scheduled
open public hearing session, FDA may from sale for reasons of safety or withdrawn from sale for safety or
conduct a lottery to determine the effectiveness. This determination means effectiveness reasons, the Agency will
speakers for the scheduled open public that FDA will not begin procedures to initiate proceedings that could result in
hearing session. The contact person will withdraw approval of abbreviated new the withdrawal of approval of the
notify interested persons regarding their drug applications (ANDAs) that refer to ANDAs that refer to the listed drug.
request to speak by April 14, 2016. these drug products, and it will allow FDA has become aware that the drug
Closed Presentation of Data: On May FDA to continue to approve ANDAs that products listed in the table in this
5, 2016, from 8 a.m. to 9:15 a.m., the refer to the products as long as they document are no longer being marketed.
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![13798 Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices
Active Dosage Form/
Application No. Drug Name Strength(s) Applicant
Ingredient(s) Route
NDA 011602 ......... KENALOG ............ Triamcinolone 0.025%; 0.1% ..................................... Lotion; Topical ..... Delcor Asset Corp.
Acetonide.
NDA 016059 ......... INDOCIN .............. Indomethacin ....... 25 milligrams (mg); 50 mg ................. Capsule; Oral ....... Iroko Pharma-
ceuticals, LLC.
NDA 017560 ......... BACTRIM and Sulfamethoxazole; 200 mg/5 milliliters (mL); 40 mg/5 mL Suspension; Oral Mutual Pharma-
BACTRIM PEDI- Trimethoprim. ceutical Com-
ATRIC. pany, Inc.
NDA 017598 ......... SEPTRA and Sulfamethoxazole; 200 mg/5 mL; 40 mg/5 mL ................. Suspension; Oral Monarch Pharma-
SEPTRA Trimethoprim. ceuticals, Inc.
GRAPE.
NDA 018185 ......... INDOCIN SR ........ Indomethacin ....... 75 mg ................................................. Extended-Release Iroko Pharma-
Capsule; Oral. ceuticals, LLC.
NDA 018450 ......... NITROPRESS ...... Sodium 50 mg/vial ........................................... Injectable; Injec- AbbVie Inc.
Nitroprusside. tion.
NDA 019834 ......... PLENDIL .............. Felodipine ............ 2.5 mg; 5 mg; 10 mg .......................... Extended-Release AstraZeneca.
Tablet; Oral.
NDA 021475 ......... METHYLIN ........... Methylphenidate 2.5 mg; 5 mg; 10 mg .......................... Chewable Tablet; Mallinckrodt Phar-
Hydrochloride. Oral. maceuticals.
NDA 050320 ......... UNIPEN ................ Nafcillin Sodium ... Equal to (EQ) 500 mg base/vial; EQ Injectable; Injec- Wyeth Ayerst
1 g (gram) base/vial; EQ 2 g base/ tion. Pharma-
vial; EQ 4 g base/vial; EQ 10 g ceuticals.
base/vial; EQ 20 g base/vial.
NDA 050406 ......... KEFLEX ............... Cephalexin ........... EQ 125 mg base/5 mL; EQ 250 mg For Suspension; Shionogi Inc.
base/5 mL; EQ 100 mg base/mL. Oral.
ANDA 060576 ...... MYCOLOG–II ....... Nystatin; 100,000 units/g; 0.1% ........................ Cream; Topical ..... Delcor Asset Corp.
Triamcinolone
Acetonide.
ANDA 062117 ...... CEPHALEXIN ...... Cephalexin ........... EQ 125 mg base/5 mL; EQ 250 mg For suspension; Facta Farmaceutici
base/5 mL; EQ 100 mg base/mL. Oral. S.p.A.
ANDA 062606 ...... MYCOLOG–II ....... Nystatin; 100,000 units/g; 0.1% ........................ Cream; Topical ..... Delcor Asset Corp.
Triamcinolone
Acetonide.
ANDA 062717 ...... UNIPEN ............... Nafcillin Sodium ... EQ 500 mg base/vial; EQ 1 g base/ Injectable; Injec- Wyeth Ayerst
vial; EQ 2 g base/vial. tion. Pharma-
ceuticals.
FDA has reviewed its records and, Dated: March 9, 2016. Draft Guidance for Industry.’’ The draft
under § 314.161, has determined that Leslie Kux, guidance document provides blood
the drug products listed in this Associate Commissioner for Policy. collection establishments and
document were not withdrawn from [FR Doc. 2016–05717 Filed 3–14–16; 8:45 am] transfusion services with
sale for reasons of safety or BILLING CODE 4164–01–P recommendations to control the risk of
effectiveness. Accordingly, the Agency bacterial contamination of room
will continue to list the drug products temperature stored platelets intended
listed in this document in the DEPARTMENT OF HEALTH AND for transfusion through the
‘‘Discontinued Drug Product List’’ HUMAN SERVICES implementation of pathogen reduction
section of the Orange Book. The technology (PRT) or bacterial testing.
Food and Drug Administration The draft guidance also provides
‘‘Discontinued Drug Product List’’
identifies, among other items, drug [Docket No. FDA–2014–D–1814] recommendations for the use of
products that have been discontinued secondary testing of platelets as the
from marketing for reasons other than Bacterial Risk Control Strategies for basis to extend the dating period of
safety or effectiveness. Blood Collection Establishments and platelets, when appropriately labeled
Transfusion Services To Enhance the bacterial detection devices and storage
Approved ANDAs that refer to the Safety and Availability of Platelets for containers are used. The draft guidance
NDAs and ANDAs listed in this Transfusion; Draft Guidance for replaces the draft guidance entitled
document are unaffected by the Industry; Availability ‘‘Bacterial Detection Testing by Blood
discontinued marketing of the products Collection Establishments and
subject to those NDAs and ANDAs. AGENCY: Food and Drug Administration,
HHS. Transfusion Services to Enhance the
Additional ANDAs that refer to these Safety and Availability of Platelets for
products may also be approved by the ACTION: Notice of availability.
Transfusion,’’ dated December 2014.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Agency if they comply with relevant SUMMARY: The Food and Drug The draft guidance, when finalized, is
legal and regulatory requirements. If Administration (FDA or Agency) is intended to supersede the
FDA determines that labeling for these announcing the availability of a draft recommendation in section VII.A.2, in
drug products should be revised to meet document entitled ‘‘Bacterial Risk regard to bacterial contamination testing
current standards, the Agency will Control Strategies for Blood Collection in the document entitled ‘‘Guidance for
advise ANDA applicants to submit such Establishments and Transfusion Industry and FDA Review Staff:
labeling. Services to Enhance the Safety and Collection of Platelets by Automated
Availability of Platelets for Transfusion; Methods’’ dated December 2007.
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Document Created: 2016-03-15 04:06:54
Document Modified: 2016-03-15 04:06:54
| 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 | Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363, [email protected] | |
| FR Citation | 81 FR 13797 |
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