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[Federal Register Volume 89, Number 234 (Thursday, December 5, 2024)]
[Notices]
[Pages 96654-96655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28433]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-5354]

Determination That Bentyl Preservative Free (Dicyclomine 
Hydrochloride) Injection, 10 Milligrams/Milliliters, 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Products Were Not Withdrawn From Sale for Reasons of Safety or 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withdrawn from sale for reasons of safety or effectiveness.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.
    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)         route          Strength(s)       Applicant
----------------------------------------------------------------------------------------------------------------
NDA 008370.............  BENTYL            Dicyclomine       Injectable;       10 Milligrams     AbbVie.
                          PRESERVATIVE      Hydrochloride.    Injection.        (mg)/
                          FREE.                                                 Milliliters
                                                                                (mL).
NDA 012104.............  KENALOG.........  Triamcinolone     Spray; Topical..  0.147 mg/Gram     Sun
                                            Acetonide.                          (g).              Pharmaceutical
                                                                                                  Industries
                                                                                                  Limited.
NDA 017806.............  THALLOUS          Thallous          Injectable;       1 Millicurie      Lantheus.
                          CHLORIDE TL 201.  Chloride TL-201.  Intravenous.      (mCi)/mL; 2 mCi/
                                                                                mL.
NDA 017823.............  HALOG...........  Halcinonide.....  Solution;         0.10%...........  Sun
                                                              Topical.                            Pharmaceutical
                                                                                                  Industries
                                                                                                  Limited.
NDA 018849.............  LIDEX...........  Fluocinonide....  Solution;         0.05%...........  Alvogen.
                                                              Topical.
NDA 020551.............  NIMBEX..........  Cisatracurium     Injectable;       Equivalent to     AbbVie.
                                            Besylate.         Injection.        (EQ) 2 mg Base/
                                                                                mL.
NDA 020551.............  NIMBEX            Cisatracurium     Injectable;       EQ 2 mg Base/mL;  AbbVie.
                          PRESERVATIVE      Besylate.         Injection.        EQ 10 mg Base/
                          FREE.                                                 mL.

[[Page 96655]]

 
NDA 020837.............  XOPENEX.........  Levalbuterol      Solution;         EQ 0.0103% Base;  Hikma.
                                            Hydrochloride.    Inhalation.       EQ 0.021% Base;
                                                                                EQ 0.042% Base;
                                                                                EQ 0.25% Base.
NDA 020857.............  COMBIVIR........  Lamivudine;       Tablet; Oral....  150 mg; 300 mg..  Viiv Health
                                            Zidovudine.                                           Care.
NDA 020977.............  ZIAGEN..........  Abacavir Sulfate  Tablet; Oral....  EQ 300 mg Base..  Viiv Health
                                                                                                  Care.
NDA 021205.............  TRIZIVIR........  Abacavir          Tablet; Oral....  EQ 300 mg Base,   Viiv Health
                                            Sulfate,                            150 mg, 300 mg.   Care.
                                            Lamivudine,
                                            Zidovudine.
NDA 021223.............  ZOMETA..........  Zoledronic Acid.  Injectable;       EQ 4 mg Base/100  Novartis.
                                                              Intravenous.      mL; EQ 4 mg
                                                                                Base/5 mL.
NDA 021548.............  LEXIVA..........  Fosamprenavir     Tablet; Oral....  EQ 700 mg Base..  Viiv Health
                                            Calcium.                                              Care.
NDA 021695.............  ANTARA            Fenofibrate.....  Capsule; Oral...  90 mg...........  Lupin.
                          (MICRONIZED).
NDA 021738.............  EXTINA..........  Ketoconazole....  Aerosol, Foam;    2%..............  Mylan.
                                                              Topical.
NDA 021861.............  PATANASE........  Olopatadine       Spray, Metered;   0.665 mg/Spray..  Novartis.
                                            Hydrochloride.    Nasal.
NDA 022128.............  SELZENTRY.......  Maraviroc.......  Tablet; Oral....  25 mg; 75 mg....  Viiv Health
                                                                                                  Care.
NDA 022350.............  ONGLYZA.........  Saxagliptin       Tablet; Oral....  EQ 2.5 mg Base;   AstraZeneca AB.
                                            Hydrochloride.                      EQ 5 mg Base.
NDA 050440.............  KEFLET..........  Cephalexin......  Tablet; Oral....  EQ 250 mg Base;   Eli Lilly and
                                                                                EQ 500 mg Base.   Company.
NDA 050558.............  ZINACEF.........  Cefuroxime        Injectable;       EQ 750 mg Base/   PAI Pharma.
                                            Sodium.           Intramuscular,    Vial; EQ 1.5 g
                                                              Intravenous.      Base/Vial; EQ
                                                                                7.5 g Base/Vial.
NDA 050567.............  POLYTRIM........  Polymyxin B       Solution/Drops;   10,000 Units/mL,  Allergan.
                                            Sulfate,          Ophthalmic.       EQ 1 mg Base/mL.
                                            Trimethoprim
                                            Sulfate.
NDA 050588.............  CEFOTAN.........  Cefotetan         Injectable;       EQ 10 g Base/     PAI Pharma.
                                            Disodium.         Injection.        Vial.
NDA 050795.............  DORYX...........  Doxycycline       Tablet, Delayed   EQ 75 mg Base;    Mayne Pharma.
                                            Hyclate.          Release; Oral.    EQ 150 mg Base.
NDA 200678.............  KOMBIGLYZE XR...  Metformin         Tablet, Extended  500 mg, EQ 5 mg   AstraZeneca AB.
                                            Hydrochloride,    Release; Oral.    Base; 1 g, EQ 5
                                            Saxagliptin                         mg Base; 1 g,
                                            Hydrochloride.                      EQ 2.5 mg Base.
NDA 201194.............  OXYCODONE         Oxycodone         Solution; Oral..  5 mg/5 mL.......  VistaPharm,
                          HYDROCHLORIDE.    Hydrochloride.                                        LLC.
NDA 204427.............  KERYDIN.........  Tavaborole......  Solution;         5%..............  Anacor
                                                              Topical.                            Pharmaceutical
                                                                                                  s, Inc.
NDA 204592.............  ZORVOLEX........  Diclofenac......  Capsule; Oral...  35 mg...........  Zyla.
NDA 204790.............  TIVICAY.........  Dolutegravir      Tablet; Oral....  EQ 10 mg Base;    Viiv Health
                                            Sodium.                             EQ 25 mg Base.    Care.
NDA 215868.............  MIDAZOLAM IN      Midazolam.......  Solution;         50 mg/50 mL (1    Exela Pharma.
                          0.8% SODIUM                         Intravenous.      mg/mL).
                          CHLORIDE.
----------------------------------------------------------------------------------------------------------------

    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: November 27, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-28433 Filed 12-4-24; 8:45 am]
BILLING CODE 4164-01-P
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