2024-07494. Determination That NALFON (Fenoprofen Calcium) Oral Capsules, Equivalent to 300 Milligram Base, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness  

  • Start Preamble

    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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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.

    Start Further Info

    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, Stacy.Kane@fda.hhs.gov.

    End Further Info End Preamble Start Supplemental Information

    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approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).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 § 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.

    Application No.Drug nameActive ingredient(s)Strength(s)Dosage form/routeApplicant
    NDA 017604NALFONFenoprofen CalciumEquivalent to (EQ) 300 Milligrams (mg) BaseCapsule; OralXspire Pharma.
    NDA 017087ETHRANEEnflurane99.9%Liquid; InhalationBaxter Healthcare Corp.
    NDA 018801STERILE WATER FOR INJECTIONSterile Water For Injection100% (1 Milliliter (mL)); 100% (5.2 mL)Liquid; N/AHospira, A Pfizer Company.
    NDA 019152CALAN SRVerapamil Hydrochloride120 mg; 180 mg, 240 mgTablet, Extended Release; OralPfizer Inc.
    NDA 019885ACCUPRILQuinapril HydrochlorideEQ 5 mg Base; EQ 10 mg Base; EQ 20 mg Base; EQ 40 mg BaseTablet; OralPfizer Pharmaceuticals Ltd.
    Start Printed Page 24842
    NDA 019941EMLALidocaine; Prilocaine2.5%; 2.5%Cream; TopicalTeva Branded Pharmaceutical Products R & D Inc.
    NDA 020105TRIOSTATLiothyronine SodiumEQ 0.01 mg Base/mLInjectable; InjectionPar Sterile Products, LLC.
    NDA 020125ACCURETICHydrochlorothiazide; Quinapril Hydrochloride12.5 mg, EQ 10 mg Base; 12.5 mg, EQ 20 mg Base; 25 mg, EQ 20 mg BaseTablet; OralPfizer Pharmaceuticals Ltd.
    NDA 020406PREVACIDLansoprazole15 mgCapsule, Delayed Release Pellets; OralTakeda Pharmaceuticals USA, Inc.
    NDA 020666ALBENZAAlbendazole200 mgTablet; OralImpax Laboratories Inc.
    NDA 020723ALDARAImiquimod5%Cream; TopicalBausch Health US LLC.
    NDA 020972SUSTIVAEfavirenz50 mg; 200 mgCapsule; OralBristol Myers Squibb Co.
    NDA 021009ALOCRILNedocromil Sodium2%Solution/Drops; OphthalmicAllergan Inc.
    NDA 021526RANEXARanolazine500 mg; 1 gTablet, Extended Release; OralMenarini International Operations Luxembourg SA.
    NDA 021565ELESTATEpinastine Hydrochloride0.05%Solution/Drops; OphthalmicAllergan Inc.
    NDA 021775ENTEREGAlvimopan12 mgCapsule; OralCubist Pharmaceuticals, Inc.
    NDA 021790DACOGENDecitabine50 mg/VialInjectable; IntravenousOtsuka Pharmaceutical Co., Ltd.
    NDA 050095CAPASTAT SULFATECapreomycin SulfateEQ 1 g Base/VialInjectable; InjectionEpic Pharma, LLC.
    NDA 050795DORYXDoxycycline HyclateEQ 50 mg Base; EQ 100 mg Base; EQ 120 mg BaseTablet, Delayed Release; OralMayne Pharma International Pty Ltd.
    NDA 050801EVOCLINClindamycin Phosphate1%Aerosol, Foam; TopicalMylan Pharmaceuticals Inc.
    NDA 200179STAXYNVardenafil Hydrochloride10 mgTablet, Orally Disintegrating; OralBayer Healthcare Pharmaceuticals Inc.
    NDA 202515MORPHINE SULFATEMorphine Sulfate15 mg/mLInjectable; InjectionHospira, A Pfizer Company.
    NDA 203667MINASTRIN 24 FEEthinyl Estradiol; Norethindrone Acetate0.02mg, 1mgTablet; OralAllergan Pharmaceuticals International, Ltd.
    NDA 210854XOFLUZABaloxavir Marboxil20 mgTablet; OralGenentech, Inc.

    FDA has reviewed its records and, under § 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.

    Start Signature

    Dated: April 4, 2024.

    Lauren K. Roth,

    Associate Commissioner for Policy.

    End Signature End Supplemental Information

    [FR Doc. 2024-07494 Filed 4-8-24; 8:45 am]

    BILLING CODE 4164-01-P

Document Information

Published:
04/09/2024
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2024-07494
Pages:
24841-24842 (2 pages)
Docket Numbers:
Docket No. FDA-2024-N-1569
PDF File:
2024-07494.pdf