[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]


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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Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety 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.

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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withdrawn from sale for reasons of safety or effectiveness.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]]



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          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.
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    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