2024-27048. Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability

Table 1—New Draft Product-Specific Guidances for Drug Products
Active ingredient(s)
Acalabrutinib maleate.
Adapalene; Benzoyl peroxide; Clindamycin phosphate.
Allopurinol.
Aripiprazole.
Aripiprazole lauroxil.
Buspirone hydrochloride.
Cantharidin.
Cefazolin sodium.
Clonazepam.
Cyclosporine
( print page 91765)
Dexamethasone; Neomycin sulfate; Polymyxin b sulfate.
Enfuvirtide.
Eplontersen sodium.
Estrogens, conjugated.
Icatibant acetate.
Macitentan; Tadalafil.
Magnesium sulfate; Polyethylene glycol 3350; Potassium chloride; Sodium chloride; Sodium sulfate.
Memantine hydrochloride.
Mitomycin.
Paclitaxel.
Palovarotene.
Pemetrexed disodium.
Phentolamine mesylate.
Phytonadione (multiple reference listed drugs).
Quizartinib dihydrochloride.
Risperidone.
Ritlecitinib tosylate.
Treprostinil.

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).
Allopurinol.
Azelaic acid.
Bictegravir sodium; Emtricitabine; Tenofovir alafenamide fumarate.
Budesonide; Formoterol fumarate dihydrate.
Enzalutamide.
Ferric carboxymaltose.
Ferumoxytol.
Fluticasone propionate.
Fluticasone propionate; Salmeterol xinafoate.
Formoterol fumarate.
Formoterol fumarate; Mometasone furoate.
Labetalol hydrochloride.
Lenvatinib mesylate.
Levonorgestrel.
Liraglutide.
Losartan potassium.
Mometasone furoate.
Nepafenac (multiple reference listed drugs).
Nitroglycerin.
Olaparib.
Phytonadione (multiple reference listed drugs).
Primidone.
Rasagiline mesylate.
Ruxolitinib phosphate.
Salmeterol xinafoate.
Tacrolimus.
Tazarotene.
Tiotropium bromide.
Tramadol hydrochloride.

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Document Information

Published:: 11/20/2024
Department:: Food and Drug Administration
Entry Type:: Notice
Action:: Notice of availability.
Document Number:: 2024-27048
Dates:: Submit either electronic or written comments on the draft guidance by January 21, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Pages:: 91763-91765 (3 pages)
Docket Numbers:: Docket No. FDA-2007-D-0369
PDF File:: 2024-27048.pdf
Supporting Documents:: » PSG_212725 - Draft Guidance on Entrectinib re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability; » PSG_212477 - Draft Guidance on Ledipasvir; Sofosbuvir re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability; » PSG_212320 - Draft Guidance on Ferric Maltol re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability; » PSG_208612 - Draft Guidance on Ethinyl Estradiol; Levonorgestrel re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability; » PSG_206089 - Draft Guidance on Testosterone Undecanoate re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability; » PSG_022201 - Draft Guidance on Degarelix Acetate 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