[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Notices]
[Pages 64928-64929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17649]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3531]


Determination That DELATESTRYL (Testosterone Enanthate) 
Injection, 200 Milligrams/Milliliter, 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Withdrawn From Sale for Reasons of Safety or Effectiveness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withdrawn from sale for reasons of safety or effectiveness.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. 6236, Silver Spring, MD 20993-0002, 301-796-8363, 
[email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of 
an ANDA to market a generic version of a previously approved drug 
product. To obtain approval, the ANDA applicant must show, among other 
things, that the generic drug product: (1) has the same active 
ingredient(s), dosage form, route of administration, strength, 
conditions of use, and (with certain exceptions) labeling as the listed 
drug, which is a version of the drug that was previously approved, and 
(2) is bioequivalent to the listed drug. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act 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.

[[Page 64929]]

    FDA has become aware that the drug products listed in the table are 
no longer being marketed.

              Table 1--Drug Products Not Withdrawn From Sale for Reasons of Safety or Effectiveness
----------------------------------------------------------------------------------------------------------------
                                               Active                           Dosage form/
    Application No.         Drug name       ingredient(s)      Strength(s)          route           Applicant
----------------------------------------------------------------------------------------------------------------
NDA 009165............  DELATESTRYL.....  Testosterone      200 Milligrams    Injectable;       Endo
                                           Enanthate.        (mg)/Milliliter   Injection.        Pharmaceuticals
                                                             (mL).                               Inc.
NDA 011145............  DIURIL..........  Chlorothiazide    Equivalent to     Injectable;       Rising Pharma
                                           Sodium.           (EQ) 500 mg       Injection.        Holdings Inc.
                                                             base/Vial.
NDA 013217............  SKELAXIN........  Metaxalone......  800 mg..........  Tablet; Oral....  King
                                                                                                 Pharmaceuticals
                                                                                                 Research and
                                                                                                 Development
                                                                                                 LLC, a
                                                                                                 subsidiary of
                                                                                                 Pfizer Inc.
NDA 017710............  NALFON..........  Fenoprofen        EQ 600 mg Base..  Tablet; Oral....  Dista Products
                                           Calcium.                                              Co., a division
                                                                                                 of Eli Lilly
                                                                                                 and Co.
NDA 018716............  TRANDATE........  Labetalol         100 mg; 200 mg;   Tablet; Oral....  Alvogen Inc.
                                           Hydrochloride.    300 mg.
NDA 018827............  LOTRISONE.......  Betamethasone     EQ 0.05% Base;    Cream; Topical..  Organon LLC, a
                                           Dipropionate;     1%.                                 subsidiary of
                                           Clotrimazole.                                         Organon and Co.
NDA 020080............  IMITREX.........  Sumatriptan       EQ 6 mg Base/0.5  Injectable;       GlaxoSmithKline.
                                           Succinate.        mL (EQ 12 mg      Subcutaneous.
                                                             Base/mL).
NDA 020617............  PYTEST KIT......  Urea, C-14......  1 mCi...........  Capsule; Oral...  Avent Inc.
NDA 020763............  AMERGE..........  Naratriptan       EQ 1 mg Base; EQ  Tablet; Oral....  GlaxoSmithKline.
                                           Hydrochloride.    2.5 mg Base.
NDA 020897............  DITROPAN XL.....  Oxybutynin        5 mg; 10 mg.....  Tablet, Extended  Janssen
                                           Chloride.                           Release; Oral.    Pharmaceuticals
                                                                                                 Inc.
NDA 020918............  GLUCAGEN........  Glucagon          EQ 1 mg Base/     Injectable;       Novo Nordisk
                                           Hydrochloride.    Vial.             Injection.        Pharmaceuticals
                                                                                                 Inc.
NDA 020928............  GLUCAGON........  Glucagon........  1 mg/Vial.......  Injectable;       Eli Lilly and
                                                                               Injection.        Co.
NDA 021615............  RAZADYNE ER.....  Galantamine       EQ 8 mg Base; EQ  Capsule,          Janssen
                                           Hydrobromide.     16 mg Base; EQ    Extended          Pharmaceuticals
                                                             24 mg Base.       Release; Oral.    Inc.
NDA 021627............  NAMENDA.........  Memantine         2 mg/mL.........  Solution; Oral..  Allergan Sales
                                           Hydrochloride.                                        LLC.
NDA 021652............  EPZICOM.........  Abacavir          EQ 600 mg Base,   Tablet; Oral....  ViiV Healthcare
                                           Sulfate;          300 mg.                             Co.
                                           Lamivudine.
NDA 021743............  TARCEVA.........  Erlotinib         EQ 25 mg Base;    Tablet; Oral....  OSI
                                           Hydrochloride.    EQ 100 mg Base;                     Pharmaceuticals
                                                             EQ 150 mg Base.                     LLC.
NDA 021892............  OSMOPREP........  Sodium            0.398 grams       Tablet; Oral....  Salix
                                           Phosphate,        (g)m; 1.102 (g).                    Pharmaceuticals
                                           Dibasic,                                              Inc.
                                           Anhydrous;
                                           Sodium
                                           Phosphate,
                                           Monobasic,
                                           Monohydrate.
NDA 022013............  OLUX E..........  Clobetasol        0.05%...........  Aerosol, Foam;    Mylan
                                           Propionate.                         Topical.          Pharmaceuticals
                                                                                                 Inc.
NDA 022204............  GELNIQUE........  Oxybutynin        10% (100 mg/      Gel; Transdermal  Abbvie Inc.
                                           Chloride.         Packet).
NDA 022525............  NAMENDA XR......  Memantine         7 mg............  Capsule,          Abbvie Inc.
                                           Hydrochloride.                      Extended
                                                                               Release; Oral.
NDA 050168............  CORTISPORIN.....  Bacitracin Zinc;  400 units/g 1%,   Ointment;         Monarch
                                           Hydrocortisone;   EQ 3.5 mg Base/   Topical.          Pharmaceuticals
                                           Neomycin          g, 5,000 units/                     LLC.
                                           Sulfate;          g.
                                           Polymyxin B
                                           Sulfate.
NDA 050218............  CORTISPORIN.....  Hydrocortisone    0.5%, EQ 3.5 mg   Cream; Topical..  Monarch
                                           Acetate;          Base/g, 10,000                      Pharmaceuticals
                                           Neomycin          units/g.                            LLC.
                                           Sulfate;
                                           Polymyxin B
                                           Sulfate.
NDA 050278............  ACHROMYCIN V....  Tetracycline      250 mg; 500 mg..  Capsule; Oral...  Avet
                                           Hydrochloride.                                        Pharmaceuticals
                                                                                                 Inc.
NDA 050578............  FORTAZ..........  Ceftazidime.....  500 mg/Vial; 1 g/ Injectable;       PAI Holdings LLC
                                                             Vial; 2 g/Vial;   Injection.        DBA
                                                             6 g/Vial.                           Pharmaceutical
                                                                                                 Associates Inc.
NDA 050679............  MAXIPIME........  Cefepime          EQ 500 mg Base/   Injectable;       Hospira Inc.
                                           Hydrochloride.    Vial; EQ 1 g      Injection.
                                                             Base/Vial; EQ 2
                                                             g Base/Vial.
NDA 202543............  LEVETIRACETAM IN  Levetiracetam...  250 mg/50 mL (5   Injectable;       HQ Specialty
                         SODIUM CHLORIDE.                    mg/mL).           Intravenous.      Pharma Corp.
----------------------------------------------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has 
determined that the drug products listed were not withdrawn from sale 
for reasons of safety or effectiveness. Accordingly, the Agency will 
continue to list the drug products 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 drug products listed are 
unaffected by the discontinued marketing of the products subject to 
these applications. 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: August 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17649 Filed 8-7-24; 8:45 am]
BILLING CODE 4164-01-P