89 FR 211 pgs. 86811-86822 - Product-Specific Guidances; Revised Draft Guidances for Industry; Availability
Type: NOTICEVolume: 89Number: 211Pages: 86811 - 86822
Pages: 86811, 86812, 86813, 86814, 86822Docket number: [Docket No. FDA-2007-D-0369]
FR document: [FR Doc. 2024-25391 Filed 10-30-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
[top]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369]
Product-Specific Guidances; Revised Draft Guidances for Industry; Availability
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Submit either electronic or written comments on the draft guidance by December 30, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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:
[top] • 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
• 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
[top] FDA is announcing the availability of revised draft product-specific guidances for industry for drug products containing the following active ingredients:
[top]
| Active ingredient(s) |
|---|
| Abacavir sulfate |
| Abacavir sulfate; Dolutegravir sodium; Lamivudine (multiple reference listed drugs) |
| Abacavir sulfate; Lamivudine |
| Abacavir sulfate; Lamivudine; Zidovudine |
| Abemaciclib |
| Abrocitinib |
| Acalabrutinib |
| Acetaminophen; Aspirin; Caffeine |
| Acetaminophen; Benzhydrocodone hydrochloride |
| Acetaminophen; Butalbital; Caffeine; Codeine phosphate |
| Acetaminophen; Ibuprofen |
| Acetaminophen; Propoxyphene napsylate |
| Acetaminophen; Tramadol hydrochloride |
| Acetazolamide |
| Acetylcysteine |
| Acrivastine; Pseudoephedrine hydrochloride |
| Acyclovir (multiple reference listed drugs) |
| Adagrasib |
| Adefovir dipivoxil |
| Albuterol sulfate |
| Allopurinol; Lesinurad |
| Almotriptan malate |
| Alogliptin benzoate |
| Alogliptin benzoate; Metformin hydrochloride |
| Alogliptin benzoate; Pioglitazone hydrochloride |
| Alosetron hydrochloride |
| Alprazolam (multiple reference listed drugs) |
| Amantadine hydrochloride (multiple reference listed drugs) |
| Ambrisentan |
| Amifampridine phosphate |
| Amiloride hydrochloride |
| Aminocaproic acid |
| Amiodarone hydrochloride |
| Amitriptyline hydrochloride |
| Amitriptyline hydrochloride; Chlordiazepoxide |
| Amlodipine benzoate |
| Amlodipine besylate |
| Amlodipine besylate; Atorvastatin calcium |
| Amlodipine besylate; Benazepril hydrochloride |
| Amlodipine besylate; Celecoxib |
| Amlodipine besylate; Hydrochlorothiazide; Olmesartan medoxomil |
| Amlodipine besylate; Hydrochlorothiazide; Valsartan |
| Amlodipine besylate; Olmesartan medoxomil |
| Amlodipine besylate; Perindopril arginine |
| Amlodipine besylate; Valsartan |
| Amoxicillin (multiple reference listed drugs) |
| Amoxicillin; Clarithromycin; Vonoprazan fumarate |
| Amoxicillin; Clavulanate potassium (multiple reference listed drugs) |
| Amoxicillin; Vonoprazan fumarate |
| Amphetamine aspartate; Amphetamine sulfate; Dextroamphetamine saccharate; Dextroamphetamine sulfate |
| Anagrelide hydrochloride |
| Anastrozole |
| Apixaban |
| Apremilast |
| Aripiprazole (multiple reference listed drugs) |
| Armodafinil |
| Aspirin |
| Aspirin; Butalbital; Caffeine; Codeine phosphate |
| Atazanavir sulfate |
| Atazanavir sulfate; Cobicistat |
| Atenolol |
| Atenolol; Chlorthalidone |
| Atomoxetine hydrochloride |
| Atorvastatin calcium (multiple reference listed drugs) |
| Atorvastatin calcium; Ezetimibe |
| Atovaquone (multiple reference listed drugs) |
| Auranofin |
| Avanafil |
| Avatrombopag maleate |
| Axitinib |
| Azilsartan kamedoxomil |
| Azilsartan kamedoxomil; Chlorthalidone |
| Azithromycin (multiple reference listed drugs) |
| Baclofen (multiple reference listed drugs) |
| Baloxavir marboxil (multiple reference listed drugs) |
| Baricitinib |
| Bedaquiline fumarate |
| Belumosudil mesylate |
| Bempedoic acid |
| Bempedoic acid; Ezetimibe |
| Benazepril hydrochloride |
| Benazepril hydrochloride; Hydrochlorothiazide |
| Benznidazole |
| Berotralstat hydrochloride |
| Bexagliflozin |
| Bicalutamide |
| Binimetinib |
| Bisoprolol fumarate |
| Bisoprolol fumarate; Hydrochlorothiazide |
| Boceprevir |
| Bosentan (multiple reference listed drugs) |
| Bosutinib monohydrate |
| Brexpiprazole |
| Brincidofovir |
| Brivaracetam |
| Bumetanide |
| Bupropion hydrochloride |
| Buspirone hydrochloride |
| Cabotegravir sodium |
| Calcium carbonate; Famotidine; Magnesium hydroxide |
| Canagliflozin |
| Canagliflozin; Metformin hydrochloride |
| Candesartan cilexetil |
| Candesartan cilexetil; Hydrochlorothiazide |
| Capmatinib hydrochloride |
| Carbidopa |
| Carbidopa; Entacapone; Levodopa |
| Carbidopa; Levodopa (multiple reference listed drugs) |
| Carglumic acid |
| Cariprazine hydrochloride |
| Carisoprodol |
| Carvedilol |
| Cefaclor |
| Cefadroxil/cefadroxil hemihydrate |
| Cefdinir (multiple reference listed drugs) |
| Cefditoren pivoxil |
| Cefixime (multiple reference listed drugs) |
| Cefpodoxime proxetil (multiple reference listed drugs) |
| Cefprozil (multiple reference listed drugs) |
| Cefuroxime axetil (multiple reference listed drugs) |
| Celecoxib; Tramadol hydrochloride |
| Cenobamate |
| Cephalexin (multiple reference listed drugs) |
| Ceritinib (multiple reference listed drugs) |
| Cetirizine hydrochloride (multiple reference listed drugs) |
| Cevimeline hydrochloride |
| Chenodiol |
| Chlordiazepoxide hydrochloride |
| Chlordiazepoxide hydrochloride; Clidinium bromide |
| Chlorothiazide |
| Chlorpheniramine maleate; Ibuprofen; Phenylephrine hydrochloride |
| Chlorpheniramine maleate; Ibuprofen; Pseudoephedrine hydrochloride |
| Chlorpromazine hydrochloride |
| Chlorthalidone (multiple reference listed drugs) |
| Chlorzoxazone |
| Cholic acid |
| Cimetidine |
| Cinacalcet hydrochloride |
| Ciprofloxacin |
| Ciprofloxacin hydrochloride |
| Citalopram hydrobromide (multiple reference listed drugs) |
| Clarithromycin (multiple reference listed drugs) |
| Clemastine fumarate (multiple reference listed drugs) |
| Clindamycin hydrochloride |
| Clobazam (multiple reference listed drugs) |
| Clomiphene citrate |
| Clomipramine hydrochloride |
| Clonazepam (multiple reference listed drugs) |
| Clonidine hydrochloride |
| Clopidogrel bisulfate |
| Clorazepate dipotassium |
| Cobicistat |
| Cobimetinib fumarate |
| Colchicine (multiple reference listed drugs) |
| Crizotinib |
| Cyclobenzaprine hydrochloride |
| Cycloserine |
| Daclatasvir dihydrochloride |
| Dacomitinib |
| Dantrolene sodium |
| Dapagliflozin |
| Dapagliflozin; Saxagliptin hydrochloride |
| Daprodustat |
| Dapsone |
| Darolutamide |
| Darunavir (multiple reference listed drugs) |
| Dasatinib |
| Deferiprone |
| Deflazacort (multiple reference listed drugs) |
| Delafloxacin meglumine |
| Delavirdine mesylate |
| Desipramine hydrochloride |
| Desloratadine (multiple reference listed drugs) |
| Desmopressin acetate |
| Desogestrel; Ethinyl estradiol (multiple reference listed drugs) |
| Dexamethasone |
| Dexmethylphenidate hydrochloride |
| Dexmethylphenidate hydrochloride; Serdexmethylphenidate chloride |
| Dextromethorphan hydrobromide; Quinidine sulfate |
| Diazepam |
| Diazoxide |
| Dichlorphenamide |
| Diclofenac |
| Diclofenac potassium (multiple reference listed drugs) |
| Dicyclomine hydrochloride (multiple reference listed drugs) |
| Dienogest; Estradiol valerate |
| Diflunisal |
| Diphenhydramine citrate; Ibuprofen |
| Diphenhydramine hydrochloride |
| Diphenhydramine hydrochloride; Ibuprofen |
| Diphenhydramine hydrochloride; Naproxen sodium |
| Dipyridamole |
| Disopyramide phosphate |
| Disulfiram |
| Dofetilide |
| Dolasetron mesylate |
| Dolutegravir sodium (multiple reference listed drugs) |
| Dolutegravir sodium; Lamivudine |
| Dolutegravir sodium; Rilpivirine hydrochloride |
| Donepezil hydrochloride (multiple reference listed drugs) |
| Doxazosin mesylate |
| Doxepin hydrochloride (multiple reference listed drugs) |
| Doxycycline (multiple reference listed drugs) |
| Doxycycline calcium |
| Doxycycline hyclate (multiple reference listed drugs) |
| Dronedarone hydrochloride |
| Drospirenone |
| Drospirenone; Estetrol |
| Drospirenone; Estradiol |
| Drospirenone; Ethinyl estradiol (multiple reference listed drugs) |
| Drospirenone; Ethinyl estradiol; Levomefolate calcium |
| Droxidopa |
| Duvelisib |
| Elacestrant dihydrochloride |
| Eletriptan hydrobromide |
| Eliglustat tartrate |
| Eltrombopag olamine (multiple reference listed drugs) |
| Eluxadoline |
| Empagliflozin |
| Empagliflozin; Linagliptin |
| Empagliflozin; Metformin hydrochloride |
| Emtricitabine |
| Emtricitabine; Rilpivirine hydrochloride; Tenofovir alafenamide fumarate |
| Emtricitabine; Rilpivirine hydrochloride; Tenofovir disoproxil fumarate |
| Emtricitabine; Tenofovir alafenamide fumarate |
| Emtricitabine; Tenofovir disoproxil fumarate |
| Enalapril maleate |
| Enasidenib mesylate |
| Entacapone |
| Eplerenone |
| Eprosartan mesylate |
| Eprosartan mesylate; Hydrochlorothiazide |
| Erdafitinib |
| Ertugliflozin; Metformin hydrochloride |
| Ertugliflozin; Sitagliptin phosphate |
| Erythromycin ethylsuccinate (multiple reference listed drugs) |
| Erythromycin ethylsuccinate; Sulfisoxazole acetyl |
| Escitalopram oxalate (multiple reference listed drugs) |
| Eslicarbazepine acetate |
| Estradiol |
| Estradiol; Norethindrone acetate |
| Estrogens, esterified |
| Eszopiclone |
| Ethacrynic acid |
| Ethambutol hydrochloride |
| Ethinyl estradiol; Ethynodiol diacetate |
| Ethinyl 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 fumarate |
| Ethinyl estradiol; Norgestimate |
| Ethinyl estradiol; Norgestrel |
| Ethionamide |
| Ethosuximide |
| Etodolac (multiple reference listed drugs) |
| Exemestane |
| Ezetimibe |
| Ezetimibe; Simvastatin |
| Ezogabine |
| Famciclovir |
| Famotidine (multiple reference listed drugs) |
| Famotidine; Ibuprofen |
| Febuxostat |
| Fedratinib hydrochloride |
| Fenofibric acid |
| Fenoprofen calcium |
| Fexofenadine hydrochloride (multiple reference listed drugs) |
| Finasteride |
| Finerenone |
| Fingolimod hydrochloride |
| Fingolimod lauryl sulfate |
| Flavoxate hydrochloride |
| Flecainide acetate |
| Flibanserin |
| Fluconazole |
| Flucytosine |
| Fludrocortisone acetate |
| Fluoxetine hydrochloride (multiple reference listed drugs) |
| Fluoxetine hydrochloride; Olanzapine |
| Fluphenazine hydrochloride |
| Flutamide |
| Fluvastatin sodium |
| Fosamprenavir calcium |
| Fosinopril sodium |
| Fosinopril sodium; Hydrochlorothiazide |
| Frovatriptan succinate |
| Furosemide |
| Futibatinib |
| Gabapentin (multiple reference listed drugs) |
| Galantamine hydrobromide |
| Ganaxolone |
| Ganciclovir |
| Gefitinib |
| Gemifloxacin mesylate |
| Gilteritinib fumarate |
| Glasdegib maleate |
| Glimepiride |
| Glimepiride; Pioglitazone hydrochloride |
| Glimepiride; Rosiglitazone maleate |
| Glipizide |
| Glipizide; Metformin hydrochloride |
| Glyburide (multiple reference listed drugs) |
| Glyburide; Metformin hydrochloride |
| Granisetron hydrochloride |
| Griseofulvin, microcrystalline; Griseofulvin, microsize |
| Guanfacine hydrochloride |
| Haloperidol |
| Hydralazine hydrochloride; Isosorbide dinitrate |
| Hydrochlorothiazide (multiple reference listed drugs) |
| Hydrochlorothiazide; Irbesartan |
| Hydrochlorothiazide; Lisinopril |
| Hydrochlorothiazide; Losartan potassium |
| Hydrochlorothiazide; Metoprolol tartrate |
| Hydrochlorothiazide; Olmesartan medoxomil |
| Hydrochlorothiazide; Quinapril hydrochloride |
| Hydrochlorothiazide; Spironolactone |
| Hydrochlorothiazide; Triamterene (multiple reference listed drugs) |
| Hydrochlorothiazide; Valsartan |
| Hydrocodone bitartrate; Ibuprofen |
| Hydrocortisone |
| Hydromorphone hydrochloride |
| Hydroxychloroquine sulfate |
| Hydroxyzine pamoate (multiple reference listed drugs) |
| Ibrexafungerp citrate |
| Ibrutinib (multiple reference listed drugs) |
| Ibuprofen (multiple reference listed drugs) |
| Ibuprofen sodium |
| Ibuprofen; Phenylephrine hydrochloride |
| Ibuprofen; Pseudoephedrine hydrochloride (multiple reference listed drugs) |
| Icosapent ethyl |
| Idelalisib |
| Iloperidone |
| Imipramine pamoate |
| Indapamide |
| Indinavir sulfate |
| Indomethacin (multiple reference listed drugs) |
| Irbesartan |
| Isavuconazonium sulfate |
| Isocarboxazid |
| Isosorbide dinitrate (multiple reference listed drugs) |
| Isradipine |
| Istradefylline |
| Ivabradine hydrochloride |
| Ketoconazole |
| Ketoprofen |
| Ketorolac tromethamine |
| Lacosamide |
| Lamivudine (multiple reference listed drugs) |
| Lamivudine; Tenofovir disoproxil fumarate (multiple reference listed drugs) |
| Lamivudine; Zidovudine |
| Lamotrigine (multiple reference listed drugs) |
| Larotrectinib sulfate |
| Lasmiditan succinate |
| Leflunomide |
| Lemborexant |
| Lenalidomide |
| Lesinurad |
| Letermovir |
| Letrozole |
| Letrozole; Ribociclib succinate |
| Leucovorin calcium |
| Levetiracetam (multiple reference listed drugs) |
| Levocarnitine |
| Levocetirizine dihydrochloride (multiple reference listed drugs) |
| Levofloxacin |
| Levonorgestrel |
| Levorphanol tartrate |
| Linagliptin |
| Linagliptin; Metformin hydrochloride |
| Linezolid (multiple reference listed drugs) |
| Lisdexamfetamine dimesylate (multiple reference listed drugs) |
| Lisinopril |
| Lofexidine hydrochloride |
| Loperamide hydrochloride (multiple reference listed drugs) |
| Loperamide hydrochloride; Simethicone |
| Loratadine (multiple reference listed drugs) |
| Lorazepam |
| Lumateperone tosylate |
| Lurasidone hydrochloride |
| Lusutrombopag |
| Macitentan |
| Maraviroc |
| Maribavir |
| Mavacamten |
| Mecamylamine hydrochloride |
| Medroxyprogesterone acetate |
| Mefenamic acid |
| Megestrol acetate |
| Meloxicam (multiple reference listed drugs) |
| Memantine hydrochloride |
| Mesna |
| Mestranol; Norethindrone |
| Metformin hydrochloride |
| Metformin hydrochloride; Pioglitazone hydrochloride |
| Metformin hydrochloride; Repaglinide |
| Metformin hydrochloride; Sitagliptin phosphate |
| Methazolamide |
| Methenamine hippurate |
| Methimazole |
| Methoxsalen (multiple reference listed drugs) |
| Methsuximide |
| Methylergonovine maleate |
| Methylphenidate hydrochloride (multiple reference listed drugs) |
| Methylprednisolone |
| Methyltestosterone |
| Metoclopramide hydrochloride (multiple reference listed drugs) |
| Metolazone |
| Metoprolol tartrate |
| Metyrosine |
| Mexiletine hydrochloride |
| Midodrine hydrochloride |
| Miglustat |
| Milnacipran hydrochloride |
| Minocycline hydrochloride (multiple reference listed drugs) |
| Minoxidil |
| Mirtazapine (multiple reference listed drugs) |
| Mitapivat sulfate |
| Mobocertinib succinate |
| Modafinil |
| Molindone hydrochloride |
| Montelukast sodium (multiple reference listed drugs) |
| Morphine sulfate |
| Moxidectin |
| Moxifloxacin hydrochloride |
| Mycophenolate mofetil (multiple reference listed drugs) |
| Nabumetone |
| Nadolol |
| Naldemedine tosylate |
| Naltrexone hydrochloride |
| Naproxen (multiple reference listed drugs) |
| Naproxen sodium (multiple reference listed drugs) |
| Naratriptan hydrochloride |
| Nateglinide |
| Nebivolol hydrochloride |
| Nebivolol hydrochloride; Valsartan |
| Neratinib maleate |
| Netupitant; Palonosetron hydrochloride |
| Nevirapine (multiple reference listed drugs) |
| Nicardipine hydrochloride |
| Nimodipine |
| Nitisinone (multiple reference listed drugs) |
| Nitrofurantoin |
| Nitrofurantoin, macrocrystalline |
| Nitrofurantoin; Nitrofurantoin, macrocrystalline |
| Norethindrone (multiple reference listed drugs) |
| Norethindrone acetate |
| Nortriptyline hydrochloride |
| Obeticholic acid |
| Olanzapine (multiple reference listed drugs) |
| Olanzapine; Samidorphan l-malate |
| Olmesartan medoxomil |
| Omaveloxolone |
| Omega-3-acid ethyl esters type a |
| Ondansetron |
| Ondansetron hydrochloride |
| Oseltamivir phosphate (multiple reference listed drugs) |
| Osilodrostat phosphate |
| Osimertinib mesylate |
| Ospemifene |
| Oteseconazole |
| Oxaprozin |
| Oxazepam |
| Oxcarbazepine (multiple reference listed drugs) |
| Oxybutynin chloride |
| Oxycodone hydrochloride (multiple reference listed drugs) |
| Oxymetholone |
| Ozanimod hydrochloride |
| Pacritinib citrate |
| Palbociclib |
| Palonosetron hydrochloride |
| Panobinostat lactate |
| Paroxetine hydrochloride |
| Paroxetine mesylate (multiple reference listed drugs) |
| Pemigatinib |
| Penbutolol sulfate |
| Penicillin v potassium |
| Perampanel (multiple reference listed drugs) |
| Perindopril erbumine |
| Perphenazine |
| Phenelzine sulfate |
| Phentermine hydrochloride |
| Pilocarpine hydrochloride |
| Pimavanserin tartrate (multiple reference listed drugs) |
| Pimozide |
| Pindolol |
| Pioglitazone hydrochloride |
| Pirfenidone (multiple reference listed drugs) |
| Piroxicam |
| Pitavastatin calcium |
| Pitavastatin magnesium |
| Pitavastatin sodium |
| Pitolisant hydrochloride |
| Pomalidomide |
| Ponesimod |
| Pramipexole dihydrochloride |
| Prasugrel hydrochloride |
| Pravastatin sodium |
| Praziquantel |
| Prazosin hydrochloride |
| Prednisolone |
| Prednisolone acetate |
| Prednisolone sodium phosphate |
| Pregabalin |
| Primaquine phosphate |
| Prochlorperazine maleate |
| Promethazine hydrochloride |
| Propafenone hydrochloride |
| Propranolol hydrochloride |
| Propylthiouracil |
| Protriptyline hydrochloride |
| Prucalopride succinate |
| Pyrazinamide |
| Pyridostigmine bromide |
| Pyrimethamine |
| Quetiapine fumarate |
| Quinapril hydrochloride |
| Raloxifene hydrochloride |
| Ramelteon |
| Ramipril (multiple reference listed drugs) |
| Ranitidine hydrochloride (multiple reference listed drugs) |
| Relugolix |
| Repaglinide |
| Reserpine |
| Ribavirin (multiple reference listed drugs) |
| Ribociclib succinate |
| Rifapentine |
| Rilpivirine hydrochloride |
| Rimegepant sulfate |
| Riociguat |
| Risperidone (multiple reference listed drugs) |
| Rivastigmine tartrate |
| Rizatriptan benzoate (multiple reference listed drugs) |
| Roflumilast |
| Rolapitant hydrochloride |
| Ropinirole hydrochloride |
| Rosiglitazone maleate |
| Rosuvastatin calcium |
| Rufinamide (multiple reference listed drugs) |
| Ruxolitinib phosphate |
| Sacubitril; Valsartan |
| Safinamide mesylate |
| Sapropterin dihydrochloride |
| Sarecycline hydrochloride |
| Saxagliptin hydrochloride |
| Selegiline hydrochloride (multiple reference listed drugs) |
| Selexipag |
| Selpercatinib |
| Sertraline hydrochloride (multiple reference listed drugs) |
| Sibutramine hydrochloride |
| Sildenafil citrate (multiple reference listed drugs) |
| Silodosin |
| Simvastatin (multiple reference listed drugs) |
| Simvastatin; Sitagliptin phosphate |
| Siponimod |
| Sitagliptin phosphate |
| Sodium phenylbutyrate (multiple reference listed drugs) |
| Sodium phenylbutyrate; Taurursodiol |
| Sofosbuvir |
| Solifenacin succinate |
| Solriamfetol hydrochloride |
| Sotalol hydrochloride (multiple reference listed drugs) |
| Sotorasib |
| Sparsentan |
| Spironolactone (multiple reference listed drugs) |
| Stavudine |
| Stiripentol (multiple reference listed drugs) |
| Succimer |
| Sulfadiazine |
| Sulfamethoxazole; Trimethoprim (multiple reference listed drugs) |
| Sumatriptan succinate |
| Tadalafil |
| Tafenoquine succinate (multiple reference listed drugs) |
| Tamoxifen citrate |
| Tapentadol hydrochloride |
| Tasimelteon |
| Tecovirimat |
| Tedizolid phosphate |
| Telbivudine |
| Telithromycin |
| Telotristat etiprate |
| Temazepam |
| Tenofovir alafenamide fumarate |
| Tenofovir disoproxil fumarate (multiple reference listed drugs) |
| Tepotinib hydrochloride |
| Terazosin hydrochloride |
| Terbinafine hydrochloride (multiple reference listed drugs) |
| Terbutaline sulfate |
| Teriflunomide |
| Testosterone undecanoate |
| Tetrabenazine |
| Tetracycline hydrochloride |
| Thioridazine hydrochloride |
| Thiothixene |
| Tiagabine hydrochloride |
| Ticagrelor |
| Ticlopidine hydrochloride |
| Timolol maleate |
| Tivozanib hydrochloride |
| Tizanidine hydrochloride |
| Tofacitinib citrate |
| Tolcapone |
| Tolterodine tartrate |
| Topiramate (multiple reference listed drugs) |
| Toremifene citrate |
| Torsemide (multiple reference listed drugs) |
| Trandolapril |
| Tranylcypromine sulfate |
| Trazodone hydrochloride |
| Triamterene |
| Triazolam |
| Triclabendazole |
| Trimethoprim |
| Trimipramine maleate |
| Ubrogepant |
| Ulipristal acetate |
| Uridine triacetate |
| Ursodiol (multiple reference listed drugs) |
| Valacyclovir hydrochloride |
| Valbenazine tosylate |
| Valganciclovir hydrochloride |
| Valsartan |
| Vandetanib |
| Vardenafil hydrochloride (multiple reference listed drugs) |
| Varenicline tartrate |
| Vericiguat |
| Vibegron |
| Vilazodone hydrochloride |
| Vismodegib |
| Vorapaxar sulfate |
| Vortioxetine hydrobromide |
| Voxelotor (multiple reference listed drugs) |
| Zalcitabine |
| Zaleplon |
| Zidovudine (multiple reference listed drugs) |
| Zileuton |
| Ziprasidone hydrochloride (multiple reference listed drugs) |
| Zolmitriptan (multiple reference listed drugs) |
| Zolpidem tartrate |
| Zonisamide |
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.
[top] 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.
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