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Home » 2024 Issues » 89 FR (08/23/2024) » 2024-18997. Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability

  2024-18997. Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability  

  • Table 1—New Draft Product-Specific Guidances for Drug Products
    Active ingredient(s)
    Air polymer-Type A.
    Fezolinetant.
    Heparin sodium; Taurolidine.
    Leniolisib phosphate.
    Naloxone hydrochloride.
    Nedosiran sodium.
    Nirmatrelvir; Ritonavir.
    Pegcetacoplan.
    Risperidone.
    Sotagliflozin.
    Tafluprost.
    Teriparatide.
    Tofersen.
    Trofinetide.

    III. Drug Products for Which Revised Draft Product-Specific Guidances Are Available

    FDA is announcing the availability of revised draft product-specific guidances for industry for drug products containing the following active ingredients:

    Table 2—Revised Draft Product-Specific Guidances for Drug Products
    Active ingredient(s)
    Albuterol sulfate.
    Albuterol sulfate; ipratropium bromide.
    Apalutamide.
    Azelaic acid.
    Bempedoic acid; Ezetimibe.
    Budesonide.
    Bupropion hydrochloride.
    Carvedilol phosphate.
    Ciprofloxacin hydrochloride; Hydrocortisone.
    Ciprofloxacin; Dexamethasone.
    Cladribine.
    Dalfampridine.
    Dapagliflozin; Metformin hydrochloride.
    Donepezil hydrochloride; Memantine hydrochloride.
    Fentanyl citrate.
    Ferric citrate.
    Fluticasone furoate; Umeclidinium bromide; Vilanterol trifenatate.
    Fluticasone propionate (multiple reference listed drugs).
    Fluticasone propionate; Salmeterol xinafoate (multiple reference listed drugs).
    Halobetasol propionate.
    Hydrochlorothiazide; Metoprolol succinate.
    Hydromorphone hydrochloride.
    Ibrutinib.
    Levalbuterol tartrate.
    Levomilnacipran hydrochloride.
    Memantine hydrochloride.
    Metformin hydrochloride; Saxagliptin hydrochloride.
    Metformin hydrochloride; Sitagliptin phosphate.
    Mometasone furoate.
    Morphine sulfate (multiple reference listed drugs).
    Naloxone hydrochloride.
    Olodaterol hydrochloride.
    Olodaterol hydrochloride; Tiotropium bromide.
    Oxcarbazepine.
    Oxymorphone hydrochloride.
    ( print page 68164)
    Phentermine hydrochloride; Topiramate.
    Posaconazole.
    Pramipexole dihydrochloride.
    Progesterone.
    Promethazine hydrochloride.
    Quetiapine fumarate.
    Tacrolimus.
    Tapentadol hydrochloride.
    Tiotropium bromide.
    Tramadol hydrochloride.
    Trospium chloride.
    Venlafaxine hydrochloride.
    Verteporfin.
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Document Information

Published:
08/23/2024
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice of availability.
Document Number:
2024-18997
Dates:
Submit either electronic or written comments on the draft guidance by October 22, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Pages:
68162-68164 (3 pages)
Docket Numbers:
Docket No. FDA-2007-D-0369
PDF File:
2024-18997.pdf
Supporting Documents:
» PSG_021497 - Draft Guidance on Nitazoxanide re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
» PSG_017604 - Draft Guidance on Fenoprofen Calcium re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
» PSG_212862 - Draft Guidance on Pretomanid
» PSG_211635 - Draft Guidance on Diazepam
» PSG_208910 - Draft Guidance on Vancomycin Hydrochloride
» PSG_207071 - Draft Guidance on Azelaic Acid
» PSG_203858 - Draft Guidance on Lomitapide Mesylate
» PSG_200063 - Draft Guidance on Bupropion Hydrochloride; Naltrexone Hydrochloride
» PSG_061904 - Draft Guidance on Erythromycin Ethylsuccinate
» PSG_050207 - Draft Guidance on Erythromycin Ethylsuccinate