Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2007-D-0369]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice of availability.
 SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the 
                        **Federal Register**
                         of June 11, 2010, FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
 DATES: Submit either electronic or written comments on the draft guidance by December 30, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
 ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way: *Federal eRulemaking Portal:**https://www.regulations.gov.*
                     Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to 
                    *https://www.regulations.gov*
                     will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a 
                    ( print page 86812)
                    third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on 
                    *https://www.regulations.gov.*
If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). Written/Paper Submissions Submit written/paper submissions as follows: *Mail/Hand Delivery/Courier (for written/paper submissions):*
                     Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” *Instructions:*
                     All submissions received must include the Docket No. FDA-2007-D-0369 for “Product-Specific Guidances; Draft and Revised Draft Guidances for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at 
                    *https://www.regulations.gov*
                     or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on*https://www.regulations.gov.*
                     Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: 
                    *https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.* *Docket:*
                     For access to the docket to read background documents or the electronic and written/paper comments received, go to 
                    *https://www.regulations.gov*
                     and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the 
                    **SUPPLEMENTARY INFORMATION**
                     section for electronic access to the draft guidance document.
 FOR FURTHER INFORMATION CONTACT: Joseph Kotsybar, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 3623A, Silver Spring, MD 20993-0002, 240-402-1062, 
                        *PSG-Questions@fda.hhs.gov.*


SUPPLEMENTARY INFORMATION: I. Background In the 
                    **Federal Register**
                     of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific guidances available to the public on FDA's website at 
                    *https://www.fda.gov/​drugs/​guidance-compliance-regulatory-information/​guidances-drugs.* As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific guidances and provide a meaningful opportunity for the public to consider and comment on those guidances. Under that process, draft guidances are posted on FDA's website and announced periodically in the 
                    **Federal Register**
                    . The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the 
                    **Federal Register**
                    . FDA considers any comments received and either publishes final guidances or publishes revised draft guidances for comment. Guidances were last announced in the 
                    **Federal Register**
                     on August 23, 2024 (89 FR 68162). This notice announces revised draft product-specific guidances that are being posted on FDA's website for a subset of immediate-release oral drug products to reflect FDA's current thinking and to align the bioequivalence recommendations with the recently adopted International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use M13A guideline titled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms” (October 2024). These revised product-specific guidances recommend that ANDA applicants conduct one bioequivalence study for products with a non-high risk of bioinequivalence due to food effect under either fasting or fed condition rather than conducting two bioequivalence studies: one BE study under fasting conditions, and one BE study under fed conditions. Other revisions, including revisions to align the recommendations in these PSGs with the recently adopted M13A guideline and editorial revisions, are incorporated as appropriate. FDA recommends that applicants consult the relevant product-specific guidance, in conjunction with general guidances on bioequivalence, when considering the design and conduct of studies supporting an evaluation of BE for immediate-release solid oral dosage forms. II. 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:
                    ( print page 86813) Table 1—Revised Draft Product-Specific Guidances for Drug Products
Active ingredient(s)Abacavir sulfateAbacavir sulfate; Dolutegravir sodium; Lamivudine (multiple reference listed drugs)Abacavir sulfate; LamivudineAbacavir sulfate; Lamivudine; ZidovudineAbemaciclibAbrocitinibAcalabrutinibAcetaminophen; Aspirin; CaffeineAcetaminophen; Benzhydrocodone hydrochlorideAcetaminophen; Butalbital; Caffeine; Codeine phosphateAcetaminophen; IbuprofenAcetaminophen; Propoxyphene napsylateAcetaminophen; Tramadol hydrochlorideAcetazolamideAcetylcysteineAcrivastine; Pseudoephedrine hydrochlorideAcyclovir (multiple reference listed drugs)AdagrasibAdefovir dipivoxilAlbuterol sulfateAllopurinol; LesinuradAlmotriptan malateAlogliptin benzoateAlogliptin benzoate; Metformin hydrochlorideAlogliptin benzoate; Pioglitazone hydrochlorideAlosetron hydrochlorideAlprazolam (multiple reference listed drugs)Amantadine hydrochloride (multiple reference listed drugs)AmbrisentanAmifampridine phosphateAmiloride hydrochlorideAminocaproic acidAmiodarone hydrochlorideAmitriptyline hydrochlorideAmitriptyline hydrochloride; ChlordiazepoxideAmlodipine benzoateAmlodipine besylateAmlodipine besylate; Atorvastatin calciumAmlodipine besylate; Benazepril hydrochlorideAmlodipine besylate; CelecoxibAmlodipine besylate; Hydrochlorothiazide; Olmesartan medoxomilAmlodipine besylate; Hydrochlorothiazide; ValsartanAmlodipine besylate; Olmesartan medoxomilAmlodipine besylate; Perindopril arginineAmlodipine besylate; ValsartanAmoxicillin (multiple reference listed drugs)Amoxicillin; Clarithromycin; Vonoprazan fumarateAmoxicillin; Clavulanate potassium (multiple reference listed drugs)Amoxicillin; Vonoprazan fumarateAmphetamine aspartate; Amphetamine sulfate; Dextroamphetamine saccharate; Dextroamphetamine sulfateAnagrelide hydrochlorideAnastrozoleApixabanApremilastAripiprazole (multiple reference listed drugs)ArmodafinilAspirinAspirin; Butalbital; Caffeine; Codeine phosphateAtazanavir sulfateAtazanavir sulfate; CobicistatAtenololAtenolol; ChlorthalidoneAtomoxetine hydrochlorideAtorvastatin calcium (multiple reference listed drugs)Atorvastatin calcium; EzetimibeAtovaquone (multiple reference listed drugs)AuranofinAvanafilAvatrombopag maleateAxitinibAzilsartan kamedoxomilAzilsartan kamedoxomil; Chlorthalidone( print page 86814)Azithromycin (multiple reference listed drugs)Baclofen (multiple reference listed drugs)Baloxavir marboxil (multiple reference listed drugs)BaricitinibBedaquiline fumarateBelumosudil mesylateBempedoic acidBempedoic acid; EzetimibeBenazepril hydrochlorideBenazepril hydrochloride; HydrochlorothiazideBenznidazoleBerotralstat hydrochlorideBexagliflozinBicalutamideBinimetinibBisoprolol fumarateBisoprolol fumarate; HydrochlorothiazideBoceprevirBosentan (multiple reference listed drugs)Bosutinib monohydrateBrexpiprazoleBrincidofovirBrivaracetamBumetanideBupropion hydrochlorideBuspirone hydrochlorideCabotegravir sodiumCalcium carbonate; Famotidine; Magnesium hydroxideCanagliflozinCanagliflozin; Metformin hydrochlorideCandesartan cilexetilCandesartan cilexetil; HydrochlorothiazideCapmatinib hydrochlorideCarbidopaCarbidopa; Entacapone; LevodopaCarbidopa; Levodopa (multiple reference listed drugs)Carglumic acidCariprazine hydrochlorideCarisoprodolCarvedilolCefaclorCefadroxil/cefadroxil hemihydrateCefdinir (multiple reference listed drugs)Cefditoren pivoxilCefixime (multiple reference listed drugs)Cefpodoxime proxetil (multiple reference listed drugs)Cefprozil (multiple reference listed drugs)Cefuroxime axetil (multiple reference listed drugs)Celecoxib; Tramadol hydrochlorideCenobamateCephalexin (multiple reference listed drugs)Ceritinib (multiple reference listed drugs)Cetirizine hydrochloride (multiple reference listed drugs)Cevimeline hydrochlorideChenodiolChlordiazepoxide hydrochlorideChlordiazepoxide hydrochloride; Clidinium bromideChlorothiazideChlorpheniramine maleate; Ibuprofen; Phenylephrine hydrochlorideChlorpheniramine maleate; Ibuprofen; Pseudoephedrine hydrochlorideChlorpromazine hydrochlorideChlorthalidone (multiple reference listed drugs)ChlorzoxazoneCholic acidCimetidineCinacalcet hydrochlorideCiprofloxacinCiprofloxacin hydrochlorideCitalopram hydrobromide (multiple reference listed drugs)Clarithromycin (multiple reference listed drugs)Clemastine fumarate (multiple reference listed drugs)Clindamycin hydrochloride( print page 86815)Clobazam (multiple reference listed drugs)Clomiphene citrateClomipramine hydrochlorideClonazepam (multiple reference listed drugs)Clonidine hydrochlorideClopidogrel bisulfateClorazepate dipotassiumCobicistatCobimetinib fumarateColchicine (multiple reference listed drugs)CrizotinibCyclobenzaprine hydrochlorideCycloserineDaclatasvir dihydrochlorideDacomitinibDantrolene sodiumDapagliflozinDapagliflozin; Saxagliptin hydrochlorideDaprodustatDapsoneDarolutamideDarunavir (multiple reference listed drugs)DasatinibDeferiproneDeflazacort (multiple reference listed drugs)Delafloxacin meglumineDelavirdine mesylateDesipramine hydrochlorideDesloratadine (multiple reference listed drugs)Desmopressin acetateDesogestrel; Ethinyl estradiol (multiple reference listed drugs)DexamethasoneDexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride; Serdexmethylphenidate chlorideDextromethorphan hydrobromide; Quinidine sulfateDiazepamDiazoxideDichlorphenamideDiclofenacDiclofenac potassium (multiple reference listed drugs)Dicyclomine hydrochloride (multiple reference listed drugs)Dienogest; Estradiol valerateDiflunisalDiphenhydramine citrate; IbuprofenDiphenhydramine hydrochlorideDiphenhydramine hydrochloride; IbuprofenDiphenhydramine hydrochloride; Naproxen sodiumDipyridamoleDisopyramide phosphateDisulfiramDofetilideDolasetron mesylateDolutegravir sodium (multiple reference listed drugs)Dolutegravir sodium; LamivudineDolutegravir sodium; Rilpivirine hydrochlorideDonepezil hydrochloride (multiple reference listed drugs)Doxazosin mesylateDoxepin hydrochloride (multiple reference listed drugs)Doxycycline (multiple reference listed drugs)Doxycycline calciumDoxycycline hyclate (multiple reference listed drugs)Dronedarone hydrochlorideDrospirenoneDrospirenone; EstetrolDrospirenone; EstradiolDrospirenone; Ethinyl estradiol (multiple reference listed drugs)Drospirenone; Ethinyl estradiol; Levomefolate calciumDroxidopaDuvelisibElacestrant dihydrochlorideEletriptan hydrobromideEliglustat tartrate( print page 86816)Eltrombopag olamine (multiple reference listed drugs)EluxadolineEmpagliflozinEmpagliflozin; LinagliptinEmpagliflozin; Metformin hydrochlorideEmtricitabineEmtricitabine; Rilpivirine hydrochloride; Tenofovir alafenamide fumarateEmtricitabine; Rilpivirine hydrochloride; Tenofovir disoproxil fumarateEmtricitabine; Tenofovir alafenamide fumarateEmtricitabine; Tenofovir disoproxil fumarateEnalapril maleateEnasidenib mesylateEntacaponeEplerenoneEprosartan mesylateEprosartan mesylate; HydrochlorothiazideErdafitinibErtugliflozin; Metformin hydrochlorideErtugliflozin; Sitagliptin phosphateErythromycin ethylsuccinate (multiple reference listed drugs)Erythromycin ethylsuccinate; Sulfisoxazole acetylEscitalopram oxalate (multiple reference listed drugs)Eslicarbazepine acetateEstradiolEstradiol; Norethindrone acetateEstrogens, esterifiedEszopicloneEthacrynic acidEthambutol hydrochlorideEthinyl estradiol; Ethynodiol diacetateEthinyl estradiol; Levonorgestrel (multiple reference listed drugs)Ethinyl estradiol; Norethindrone (multiple reference listed drugs)Ethinyl estradiol; Norethindrone acetate (multiple reference listed drugs)Ethinyl estradiol; Norethindrone acetate; Ethinyl estradiol; Ferrous fumarateEthinyl estradiol; NorgestimateEthinyl estradiol; NorgestrelEthionamideEthosuximideEtodolac (multiple reference listed drugs)ExemestaneEzetimibeEzetimibe; SimvastatinEzogabineFamciclovirFamotidine (multiple reference listed drugs)Famotidine; IbuprofenFebuxostatFedratinib hydrochlorideFenofibric acidFenoprofen calciumFexofenadine hydrochloride (multiple reference listed drugs)FinasterideFinerenoneFingolimod hydrochlorideFingolimod lauryl sulfateFlavoxate hydrochlorideFlecainide acetateFlibanserinFluconazoleFlucytosineFludrocortisone acetateFluoxetine hydrochloride (multiple reference listed drugs)Fluoxetine hydrochloride; OlanzapineFluphenazine hydrochlorideFlutamideFluvastatin sodiumFosamprenavir calciumFosinopril sodiumFosinopril sodium; HydrochlorothiazideFrovatriptan succinateFurosemideFutibatinib( print page 86817)Gabapentin (multiple reference listed drugs)Galantamine hydrobromideGanaxoloneGanciclovirGefitinibGemifloxacin mesylateGilteritinib fumarateGlasdegib maleateGlimepirideGlimepiride; Pioglitazone hydrochlorideGlimepiride; Rosiglitazone maleateGlipizideGlipizide; Metformin hydrochlorideGlyburide (multiple reference listed drugs)Glyburide; Metformin hydrochlorideGranisetron hydrochlorideGriseofulvin, microcrystalline; Griseofulvin, microsizeGuanfacine hydrochlorideHaloperidolHydralazine hydrochloride; Isosorbide dinitrateHydrochlorothiazide (multiple reference listed drugs)Hydrochlorothiazide; IrbesartanHydrochlorothiazide; LisinoprilHydrochlorothiazide; Losartan potassiumHydrochlorothiazide; Metoprolol tartrateHydrochlorothiazide; Olmesartan medoxomilHydrochlorothiazide; Quinapril hydrochlorideHydrochlorothiazide; SpironolactoneHydrochlorothiazide; Triamterene (multiple reference listed drugs)Hydrochlorothiazide; ValsartanHydrocodone bitartrate; IbuprofenHydrocortisoneHydromorphone hydrochlorideHydroxychloroquine sulfateHydroxyzine pamoate (multiple reference listed drugs)Ibrexafungerp citrateIbrutinib (multiple reference listed drugs)Ibuprofen (multiple reference listed drugs)Ibuprofen sodiumIbuprofen; Phenylephrine hydrochlorideIbuprofen; Pseudoephedrine hydrochloride (multiple reference listed drugs)Icosapent ethylIdelalisibIloperidoneImipramine pamoateIndapamideIndinavir sulfateIndomethacin (multiple reference listed drugs)IrbesartanIsavuconazonium sulfateIsocarboxazidIsosorbide dinitrate (multiple reference listed drugs)IsradipineIstradefyllineIvabradine hydrochlorideKetoconazoleKetoprofenKetorolac tromethamineLacosamideLamivudine (multiple reference listed drugs)Lamivudine; Tenofovir disoproxil fumarate (multiple reference listed drugs)Lamivudine; ZidovudineLamotrigine (multiple reference listed drugs)Larotrectinib sulfateLasmiditan succinateLeflunomideLemborexantLenalidomideLesinuradLetermovirLetrozoleLetrozole; Ribociclib succinate( print page 86818)Leucovorin calciumLevetiracetam (multiple reference listed drugs)LevocarnitineLevocetirizine dihydrochloride (multiple reference listed drugs)LevofloxacinLevonorgestrelLevorphanol tartrateLinagliptinLinagliptin; Metformin hydrochlorideLinezolid (multiple reference listed drugs)Lisdexamfetamine dimesylate (multiple reference listed drugs)LisinoprilLofexidine hydrochlorideLoperamide hydrochloride (multiple reference listed drugs)Loperamide hydrochloride; SimethiconeLoratadine (multiple reference listed drugs)LorazepamLumateperone tosylateLurasidone hydrochlorideLusutrombopagMacitentanMaravirocMaribavirMavacamtenMecamylamine hydrochlorideMedroxyprogesterone acetateMefenamic acidMegestrol acetateMeloxicam (multiple reference listed drugs)Memantine hydrochlorideMesnaMestranol; NorethindroneMetformin hydrochlorideMetformin hydrochloride; Pioglitazone hydrochlorideMetformin hydrochloride; RepaglinideMetformin hydrochloride; Sitagliptin phosphateMethazolamideMethenamine hippurateMethimazoleMethoxsalen (multiple reference listed drugs)MethsuximideMethylergonovine maleateMethylphenidate hydrochloride (multiple reference listed drugs)MethylprednisoloneMethyltestosteroneMetoclopramide hydrochloride (multiple reference listed drugs)MetolazoneMetoprolol tartrateMetyrosineMexiletine hydrochlorideMidodrine hydrochlorideMiglustatMilnacipran hydrochlorideMinocycline hydrochloride (multiple reference listed drugs)MinoxidilMirtazapine (multiple reference listed drugs)Mitapivat sulfateMobocertinib succinateModafinilMolindone hydrochlorideMontelukast sodium (multiple reference listed drugs)Morphine sulfateMoxidectinMoxifloxacin hydrochlorideMycophenolate mofetil (multiple reference listed drugs)NabumetoneNadololNaldemedine tosylateNaltrexone hydrochlorideNaproxen (multiple reference listed drugs)Naproxen sodium (multiple reference listed drugs)Naratriptan hydrochloride( print page 86819)NateglinideNebivolol hydrochlorideNebivolol hydrochloride; ValsartanNeratinib maleateNetupitant; Palonosetron hydrochlorideNevirapine (multiple reference listed drugs)Nicardipine hydrochlorideNimodipineNitisinone (multiple reference listed drugs)NitrofurantoinNitrofurantoin, macrocrystallineNitrofurantoin; Nitrofurantoin, macrocrystallineNorethindrone (multiple reference listed drugs)Norethindrone acetateNortriptyline hydrochlorideObeticholic acidOlanzapine (multiple reference listed drugs)Olanzapine; Samidorphan l-malateOlmesartan medoxomilOmaveloxoloneOmega-3-acid ethyl esters type aOndansetronOndansetron hydrochlorideOseltamivir phosphate (multiple reference listed drugs)Osilodrostat phosphateOsimertinib mesylateOspemifeneOteseconazoleOxaprozinOxazepamOxcarbazepine (multiple reference listed drugs)Oxybutynin chlorideOxycodone hydrochloride (multiple reference listed drugs)OxymetholoneOzanimod hydrochloridePacritinib citratePalbociclibPalonosetron hydrochloridePanobinostat lactateParoxetine hydrochlorideParoxetine mesylate (multiple reference listed drugs)PemigatinibPenbutolol sulfatePenicillin v potassiumPerampanel (multiple reference listed drugs)Perindopril erbuminePerphenazinePhenelzine sulfatePhentermine hydrochloridePilocarpine hydrochloridePimavanserin tartrate (multiple reference listed drugs)PimozidePindololPioglitazone hydrochloridePirfenidone (multiple reference listed drugs)PiroxicamPitavastatin calciumPitavastatin magnesiumPitavastatin sodiumPitolisant hydrochloridePomalidomidePonesimodPramipexole dihydrochloridePrasugrel hydrochloridePravastatin sodiumPraziquantelPrazosin hydrochloridePrednisolonePrednisolone acetatePrednisolone sodium phosphatePregabalinPrimaquine phosphate( print page 86820)Prochlorperazine maleatePromethazine hydrochloridePropafenone hydrochloridePropranolol hydrochloridePropylthiouracilProtriptyline hydrochloridePrucalopride succinatePyrazinamidePyridostigmine bromidePyrimethamineQuetiapine fumarateQuinapril hydrochlorideRaloxifene hydrochlorideRamelteonRamipril (multiple reference listed drugs)Ranitidine hydrochloride (multiple reference listed drugs)RelugolixRepaglinideReserpineRibavirin (multiple reference listed drugs)Ribociclib succinateRifapentineRilpivirine hydrochlorideRimegepant sulfateRiociguatRisperidone (multiple reference listed drugs)Rivastigmine tartrateRizatriptan benzoate (multiple reference listed drugs)RoflumilastRolapitant hydrochlorideRopinirole hydrochlorideRosiglitazone maleateRosuvastatin calciumRufinamide (multiple reference listed drugs)Ruxolitinib phosphateSacubitril; ValsartanSafinamide mesylateSapropterin dihydrochlorideSarecycline hydrochlorideSaxagliptin hydrochlorideSelegiline hydrochloride (multiple reference listed drugs)SelexipagSelpercatinibSertraline hydrochloride (multiple reference listed drugs)Sibutramine hydrochlorideSildenafil citrate (multiple reference listed drugs)SilodosinSimvastatin (multiple reference listed drugs)Simvastatin; Sitagliptin phosphateSiponimodSitagliptin phosphateSodium phenylbutyrate (multiple reference listed drugs)Sodium phenylbutyrate; TaurursodiolSofosbuvirSolifenacin succinateSolriamfetol hydrochlorideSotalol hydrochloride (multiple reference listed drugs)SotorasibSparsentanSpironolactone (multiple reference listed drugs)StavudineStiripentol (multiple reference listed drugs)SuccimerSulfadiazineSulfamethoxazole; Trimethoprim (multiple reference listed drugs)Sumatriptan succinateTadalafilTafenoquine succinate (multiple reference listed drugs)Tamoxifen citrateTapentadol hydrochlorideTasimelteonTecovirimat( print page 86821)Tedizolid phosphateTelbivudineTelithromycinTelotristat etiprateTemazepamTenofovir alafenamide fumarateTenofovir disoproxil fumarate (multiple reference listed drugs)Tepotinib hydrochlorideTerazosin hydrochlorideTerbinafine hydrochloride (multiple reference listed drugs)Terbutaline sulfateTeriflunomideTestosterone undecanoateTetrabenazineTetracycline hydrochlorideThioridazine hydrochlorideThiothixeneTiagabine hydrochlorideTicagrelorTiclopidine hydrochlorideTimolol maleateTivozanib hydrochlorideTizanidine hydrochlorideTofacitinib citrateTolcaponeTolterodine tartrateTopiramate (multiple reference listed drugs)Toremifene citrateTorsemide (multiple reference listed drugs)TrandolaprilTranylcypromine sulfateTrazodone hydrochlorideTriamtereneTriazolamTriclabendazoleTrimethoprimTrimipramine maleateUbrogepantUlipristal acetateUridine triacetateUrsodiol (multiple reference listed drugs)Valacyclovir hydrochlorideValbenazine tosylateValganciclovir hydrochlorideValsartanVandetanibVardenafil hydrochloride (multiple reference listed drugs)Varenicline tartrateVericiguatVibegronVilazodone hydrochlorideVismodegibVorapaxar sulfateVortioxetine hydrobromideVoxelotor (multiple reference listed drugs)ZalcitabineZaleplonZidovudine (multiple reference listed drugs)ZileutonZiprasidone hydrochloride (multiple reference listed drugs)Zolmitriptan (multiple reference listed drugs)Zolpidem tartrateZonisamide
 For a complete history of previously published 
                    **Federal Register**
                     notices related to product-specific guidances, go to 
                    *https://www.regulations.gov*
                     and enter Docket No. FDA-2007-D-0369. These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized, will represent the current thinking of FDA on, among other things, the product-specific design of BE studies to support ANDAs. They do not establish any rights for any person and are not binding on FDA or the public. 
                    ( print page 86822)
                    You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 While these guidances contain no collection of information, they do refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 312 for investigational new drugs have been approved under 0910-0014. The collections of information in 21 CFR part 314 for applications for FDA approval to market a new drug and in 21 CFR part 320 for bioavailability and bioequivalence requirements have been approved under OMB control number 0910-0001. IV. Electronic Access Persons with access to the internet may obtain the draft guidance at 
                    *https://www.fda.gov/​drugs/​guidance-compliance-regulatory-information/​guidances-drugs, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents,*
                     or 
                    *https://www.regulations.gov.* Dated: October 24, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs.


[FR Doc. 2024-25391 Filed 10-30-24; 8:45 am] BILLING CODE 4164-01-P