Determination That KENALOG (Triamcinolone Acetonide) Lotion and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 13797-13798 [2016-05717]

Download as PDF asabaliauskas on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices management of acute pain. The product has been formulated with the intent to provide abuse-deterrent properties. Benzhydrocodone is a hydrocodone prodrug which, according to the applicant, is rapidly converted into hydrocodone by enzymes in the gastrointestinal tract. The active drugs in this fixed-dose combination are hydrocodone and acetaminophen. The applicant has submitted data to support abuse-deterrent properties for this product. The committees will be asked to discuss whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling, and whether the nasal route of abuse is relevant for combination products made up of hydrocodone and acetaminophen. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: On May 5, 2016, from 9:15 a.m. to 5 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before April 21, 2016. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 13, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 14, 2016. Closed Presentation of Data: On May 5, 2016, from 8 a.m. to 9:15 a.m., the VerDate Sep<11>2014 17:40 Mar 14, 2016 Jkt 238001 meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the committees will discuss the drug development program of an investigational abuse-deterrent opioid product. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Stephanie L. Begansky at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: March 9, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016–05748 Filed 3–14–16; 8:45 am] BILLING CODE 4164–01–P 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. 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 SUMMARY: PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 13797 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, Stacy.Kane@fda.hhs.gov. 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 § 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. E:\FR\FM\15MRN1.SGM 15MRN1 13798 Federal Register / Vol. 81, No. 50 / Tuesday, March 15, 2016 / Notices Application No. Drug Name Active Ingredient(s) Strength(s) Dosage Form/ Route Applicant NDA 011602 ......... KENALOG ............ 0.025%; 0.1% ..................................... Lotion; Topical ..... Delcor Asset Corp. NDA 016059 ......... INDOCIN .............. Triamcinolone Acetonide. Indomethacin ....... 25 milligrams (mg); 50 mg ................. Capsule; Oral ....... NDA 017560 ......... Sulfamethoxazole; Trimethoprim. 200 mg/5 milliliters (mL); 40 mg/5 mL Suspension; Oral Sulfamethoxazole; Trimethoprim. 200 mg/5 mL; 40 mg/5 mL ................. Suspension; Oral NDA 018185 ......... BACTRIM and BACTRIM PEDIATRIC. SEPTRA and SEPTRA GRAPE. INDOCIN SR ........ Iroko Pharmaceuticals, LLC. Mutual Pharmaceutical Company, Inc. Monarch Pharmaceuticals, Inc. Indomethacin ....... 75 mg ................................................. NDA 018450 ......... NITROPRESS ...... 50 mg/vial ........................................... Iroko Pharmaceuticals, LLC. AbbVie Inc. NDA 019834 ......... PLENDIL .............. Sodium Nitroprusside. Felodipine ............ NDA 021475 ......... METHYLIN ........... NDA 050320 ......... UNIPEN ................ Methylphenidate Hydrochloride. Nafcillin Sodium ... Extended-Release Capsule; Oral. Injectable; Injection. Extended-Release Tablet; Oral. Chewable Tablet; Oral. Injectable; Injection. NDA 050406 ......... KEFLEX ............... Cephalexin ........... Shionogi Inc. ANDA 060576 ...... MYCOLOG–II ....... Delcor Asset Corp. ANDA 062117 ...... CEPHALEXIN ...... Nystatin; Triamcinolone Acetonide. Cephalexin ........... For Suspension; Oral. Cream; Topical ..... ANDA 062606 ...... MYCOLOG–II ....... EQ 125 mg base/5 mL; EQ 250 mg base/5 mL; EQ 100 mg base/mL. 100,000 units/g; 0.1% ........................ For suspension; Oral. Cream; Topical ..... Facta Farmaceutici S.p.A. Delcor Asset Corp. ANDA 062717 ...... UNIPEN ............... EQ 500 mg base/vial; EQ 1 g base/ vial; EQ 2 g base/vial. Injectable; Injection. Wyeth Ayerst Pharmaceuticals. asabaliauskas on DSK3SPTVN1PROD with NOTICES NDA 017598 ......... Nystatin; Triamcinolone Acetonide. Nafcillin Sodium ... FDA has reviewed its records and, under § 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. VerDate Sep<11>2014 17:40 Mar 14, 2016 Jkt 238001 2.5 mg; 5 mg; 10 mg .......................... 2.5 mg; 5 mg; 10 mg .......................... Equal to (EQ) 500 mg base/vial; EQ 1 g (gram) base/vial; EQ 2 g base/ vial; EQ 4 g base/vial; EQ 10 g base/vial; EQ 20 g base/vial. EQ 125 mg base/5 mL; EQ 250 mg base/5 mL; EQ 100 mg base/mL. 100,000 units/g; 0.1% ........................ 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–1814] Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ‘‘Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; SUMMARY: PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 AstraZeneca. Mallinckrodt Pharmaceuticals. Wyeth Ayerst Pharmaceuticals. Draft Guidance for Industry.’’ The draft guidance document provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion through the implementation of pathogen reduction technology (PRT) or bacterial testing. The draft guidance also provides recommendations for the use of secondary testing of platelets as the basis to extend the dating period of platelets, when appropriately labeled bacterial detection devices and storage containers are used. The draft guidance replaces the draft guidance entitled ‘‘Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,’’ dated December 2014. The draft guidance, when finalized, is intended to supersede the recommendation in section VII.A.2, in regard to bacterial contamination testing in the document entitled ‘‘Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods’’ dated December 2007. E:\FR\FM\15MRN1.SGM 15MRN1

Agencies

[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)]
[Notices]
[Pages 13797-13798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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,
Stacy.Kane@fda.hhs.gov.

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

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