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Upcoming Product-Specific Guidances for Generic Drug Product Development

Introduction

This web page provides information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective generic drug products, including the projected date of PSG publication, as a commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III). Upcoming PSGs for both complex and non-complex products that are planned to be published in the next 12 months are listed (these may be subject to change).

How often does FDA publish new and revised PSGs?

To support generic drug development and generic drug approval, FDA issues new and revised PSGs on a quarterly and as needed basis. These PSGs, including PSGs for both complex and non-complex generic drug products, when finalized, describe the agency's current thinking and expectations on how to develop generic drug products to specific reference listed drugs and are intended to assist the generic pharmaceutical industry with identifying the most appropriate methodology and evidence needed to support a specific generic drug’s approval. The published PSGs are announced in the Federal Register and made available to the public on FDA’s website.

What information is provided on this web page?

For new PSGs for generic drug products under development, this web page provides information on the active ingredient(s), the route of administration and dosage form, the reference listed drug (RLD) application number, and the planned publication month/year. In addition to this information, the list of PSGs for generic products under revision also includes the planned revision categories and brief descriptions. This web page describes FDA’s plans for issuing new and revised PSGs for both complex and non-complex generic drug products.

What do the different planned revision categories mean?

For revised PSGs, the planned revision categories briefly describe the nature of the anticipated revisions. Planned revision categories are defined as the following:

  • Critical revision: PSG revision includes additional bioequivalence (BE) study(ies) or evidence recommended that is necessary to establish BE and support FDA approval reflecting a change in the safety or effectiveness of the drug product. The critical revision has a potential impact on all ANDAs including the approved applications. Holders of approved applications are also expected to address the change in the safety or effectiveness of the drug product reflected in a critical revision to maintain its FDA approval.
  • Major revision: PSG revision includes additional BE study(ies) or evidence recommended that is necessary to establish BE and support FDA approval. Major revisions are categorized as in vivo major revisions and in vitro major revisions. Under GDUFA III, applicants or prospective applicants may request PSG teleconference if they have already commenced an in vivo bioequivalence study (i.e., the study protocol has been signed by the study sponsor and/or the contract research organization) to obtain Agency feedback on the potential impact of the new or revised PSG on its development program. Pre-submission or post-submission PSG meetings may be requested following feedback received at the PSG teleconference. Refer to GDUFA III Enhancements to the Pre-ANDA Program for additional details.
    • In vivo major revision: PSG revision includes additional in vivo bioequivalence study(ies) or evidence recommended to support FDA approval.
    • In vitro major revision: PSG revision includes additional in vitro bioequivalence study(ies) or evidence recommended to support FDA approval.
  • Minor revision: Any revision to a PSG that is not considered critical or major, including but not limited to when a PSG is to be revised to add an in vivo or in vitro BE option, to clarify recommended study design, to certain study(ies), to provide alternative (less burdensome) approaches to the currently recommended study(ies), to add information on newly approved strengths of the RLD, or to make other recommendations that would not generally result in additional recommended bioequivalence study(ies) or evidence by an ANDA applicant necessary to support FDA approval. Minor revisions include both in vivo and in vitro changes.
  • Editorial revision: PSG revision includes non-substantive changes such as updating external references, correcting grammatical issues, and streamlining the format of existing recommendations.

FDA will also provide specific information on the planned revision when such information is available for public release.

What is a complex generic drug product?

As described in the GDUFA III Commitment Letter and Classifying Approved New Drug Products and Drug-device Combination Products as Complex Products for Generic Drug Development Purposes (MAPP 5240.10), a complex generic drug product generally means the following:

  • A product with:
    • a complex active ingredient(s) (e.g., peptides, polymeric compounds, complex mixtures of APIs, naturally sourced ingredients)
    • a complex formulation (e.g., liposomes, colloids)
    • a complex route of delivery (e.g., locally acting drugs such as dermatological products and complex ophthalmological products and otic dosage forms that are formulated as suspensions, emulsions, or gels)
    • a complex dosage form (e.g., transdermals, metered dose inhalers, extended release injectables)
  • Complex drug-device combination products (e.g., auto injectors, metered dose inhalers); and
  • Other products where complexity or uncertainty concerning the approval pathway or possible alternative approaches would benefit from early scientific engagement.

How often does FDA update this web page?

This web page will be updated each time FDA issues a new quarterly PSG batch. Each update removes the published PSGs and adds any new PSG under development or revision. This advance notice will help generic drug companies to plan for their development of generic drug products.

New and Revised PSGs for Generic Drug Products

Below is the list of PSGs for both complex and non-complex generic drug products that FDA plans to issue and the list of PSGs that FDA plans to revise in the coming year. While this list reflects FDA’s effort to be transparent regarding current plans for developing PSGs for generic drug products, it should be noted that timing may be subject to change.

Planned New PSGs for Complex and Non-Complex
Generic Drug Products
Updated: July 14, 2025

Active Ingredient(s)Route of AdministrationDosage FormRLD or RS Application NumberProduct ComplexityPlanned PublicationUpdates
Abiraterone Acetate; Niraparib TosylateOralTablet216793Non-Complex08/2025Planned publication date change to a later date
Acroamidis HydrochlorideOralTablet216540Non-Complex11/2025No Change
Amikacin SulfateInhalationSuspension, Liposomal207356ComplexBeyond 12 monthsNo Change
AprocitentanOralTablet217686Non-Complex09/2025Planned publication date change to a later date
Arimoclomol CitrateOralCapsule214927Non-Complex11/2025No Change
AripiprazoleOralTablet207202ComplexWithin the next 12 monthsNo Change
AripiprazoleOralSolution021713Non-Complex11/2025No Change
Berdazimer SodiumTopicalGel217424Complex09/2025Planned publication date change to a later date
BudesonideOralSuspension213976Complex09/2025Planned publication date change to a later date
Bupivacaine; MeloxicamPeriarticularSolution, Extended Release211988Complex08/2025Planned publication date change to a later date
BuprenorphineSubcutaneousSolution, Extended Release 210136Complex02/2026Planned publication date change to a later date
CabergolineOralTablet020664Non-Complex11/2025No Change
CapivasertibOralTablet218197Non-Complex08/2025Planned publication date change to a later date
Carbidopa; LevodopaOralCapsule, Extended Release217186Non-Complex09/2025Planned publication date change to a later date
Carbidopa; LevodopaOralTablet214869Non-Complex09/2025Planned publication date change to a later date
Cefepime Hydrochloride; Enmetazobactam IntravenousPowder216165Non-Complex11/2025No Change
CephalexinOralTablet063024Non-ComplexWithin the next 12 monthsNo Change
Clobetasol PropionateTopicalCream209483ComplexBeyond 12 monthsNo Change
CrinecerfontOralCapsule218808Non-Complex11/2025No Change
CrinecerfontOralSolution218820Non-Complex11/2025No Change
CrizotinibOralCapsule, Pellets217581Non-Complex08/2025Planned publication date change to a later date
DanicopanOralTablet218037Non-Complex09/2025Planned publication date change to a later date
DasatinibOralTablet216099Non-Complex09/2025Planned publication date change to a later date
Desmopressin AcetateNasalSpray, Metered201656Complex11/2025No Change
Deuruxolitinib PhosphateOralTablet217900Non-Complex09/2025Planned publication date change to a later date
Deutivacaftor; Tezacaftor; Vanzacaftor CalciumOralTablet218730Non-Complex11/2025No Change
DexamethasoneIntravitrealImplant022315Complex09/2025Planned publication date change to a later date
Dexmedetomidine HydrochlorideBuccal; SublingualFilm215390Non-Complex08/2025Planned publication date change to a later date
ElafibranorOralTablet218860Non-Complex11/2025No Change
Eltrombopag CholineOralTablet216774Non-Complex09/2025Planned publication date change to a later date
Ensartinib HydrochlorideOralCapsule218171Non-Complex11/2025No Change
EnsifentrineInhalationSuspension217389Complex08/2025Planned publication date change to a later date
EstradiolVaginalInsert208564ComplexWithin the next 12 monthsNo Change
Estradiol; Norethindrone Acetate; RelugolixOralTablet214846Non-Complex11/2025No Change
Estradiol;ProgesteroneOralCapsule210132Non-Complex11/2025No Change
Ezetimibe; Rosuvastatin CalciumOralTablet213072Non-Complex11/2025No Change
Fenfluramine HydrochlorideOralSolution212102Non-Complex11/2025No Change
FlunisolideInhalationAerosol, Metered021247Complex09/2025Planned publication date change to a later date
Flurpiridaz F-18IntravenousSolution215168Non-Complex11/2025No Change
Foscarbidopa; FoslevodopaSubcutaneousSolution216962Complex02/2026No Change
FruquintinibOralCapsule217564Non-Complex08/2025Planned publication date change to a later date
Givinostat HydrochlorideOralSuspension217865Non-Complex09/2025Planned publication date change to a later date
GlucagonInjectionInjectable020928Complex09/2025Planned publication date change to a later date
GlycopyrrolateOralTablet, Oral Disintegrating215019Non-Complex08/2025Planned publication date change to a later date
IbrutinibOralSuspension217003Non-Complex08/2025Planned publication date change to a later date
Imetelstat SodiumIntravenousPowder217779Complex02/2026No Change
InavolisibOralTablet219249Non-Complex09/2025Planned publication date change to a later date
IomeprolIntra-arterialSolution216016Non-Complex11/2025No Change
IomeprolIntravenousSolution216017Non-Complex11/2025No Change
ItraconazoleOralSolution020657Non-Complex11/2025No Change
Ketorolac Tromethamine; Phenylephrine HydrochlorideIrrigationSolution205388Non-ComplexWithin the next 12 monthsPlanned publication date change to a later date
LacosamideOralSolution022255Non-Complex11/2025No Change
Landiolol HydrochlorideIntravenousPowder217202Non-Complex02/2026No Change
Lanreotide AcetateSubcutaneousSolution215395ComplexWithin the next 12 monthsNo change
Lazertinib MesylateOralTablet219008Non-Complex09/2025Planned publication date change to a later date
LevacetylleucineOralFor Suspension219132Non-Complex11/2025No Change
Levamlodipine MaleateOralTablet212895Non-Complex11/2025No Change
L-GlutamineOralFor Solution208587Non-Complex11/2025No Change
Lidocaine; TetracaineTopicalPatch021623ComplexBeyond 12 monthsNo Change
MavorixaforOralCapsule218709Non-Complex09/2025Planned publication date change to a later date
MetronidazoleOralSuspension216755Non-Complex09/2025Planned publication date change to a later date
Minocycline HydrochlorideOralCapsule, Extended Release219015Non-Complex09/2025Planned publication date change to a later date
Mometasone FuroateImplantationImplant209310ComplexWithin the next 12 monthsPlanned publication date change to a later date
Nalmefene HydrochlorideIntramuscular, SubcutaneousSolution218590Complex08/2025Planned publication date change to a later date
Naloxone HydrochlorideNasalSpray215487Complex08/2025Planned publication date change to a later date
NicotineOralInhalant020714Complex11/2025No Change
Nilotinib TartrateOralTablet219293Non-Complex09/2025Planned publication date change to a later date
NimodipineOralSolution203340Non-Complex11/2025No Change
Nirogacestat HydrobromideOralTablet217677Non-Complex08/2025Planned publication date change to a later date
Olezarsen SodiumSubcutaneousSolution218614Complex02/2026No Change
OxaprozinOralCapsule217927Non-Complex09/2025Planned publication date change to a later date
Paliperidone PalmitateIntramuscularSuspension, Extended Release216352Complex02/2026No Change
PalopegteriparatideSubcutaneousSolution216490Complex02/2026No Change
Patiromer Sorbitex CalciumOralPowder205739ComplexWithin the next 12 monthsNo Change
Pegulicianine AcetateIntravenousPowder214511Complex11/2025No Change
Pemetrexed DipotassiumIntravenousPowder210661Non-Complex08/2025Planned publication date change to a later date
Pivmecillinam HydrochlorideOralTablet216483Non-Complex11/2025Planned publication date change to a later date
Prednisolone AcetateOphthalmicSuspension/Drops017100Complex08/2025Planned publication date change to a later date
PrimidoneOralOrally Disintegrating TabletFDA-2009-P-0481 Non-Complex11/2025Planned publication date change to a later date
Probenecid; Sulopenem EtzadroxilOralTablet213972Non-Complex09/2025Planned publication date change to a later date
ResmetiromOralTablet217785Non-Complex09/2025Planned publication date change to a later date
Revumenib CitrateOralTablet218944Non-Complex11/2025No Change
RoflumilastTopicalFoam217242Complex11/2025No Change
Sacubitril; ValsartanOralCapsule, Pellets218591Non-Complex09/2025Planned publication date change to a later date
Sapropterin DihydrochlorideOralPowder205065Non-Complex08/2025Planned publication date change to a later date
Seladelpar Lysine OralCapsule217899Non-Complex09/2025Planned publication date change to a later date
SelpercatinibOralTablet218160Non-Complex11/2025No Change
Sofpironium BromideTopicalGel, Metered217347Complex08/2025Planned publication date change to a later date
Tenapanor HydrochlorideOralTablet213931Complex11/2025Planned publication date change to a later date
TeriparatideSubcutaneousSolution218771Complex11/2025No Change
TirzepatideSubcutaneousSolution217806Complex09/2025Planned publication date change to a later date
TovorafenibOralFor Suspension218033Non-Complex09/2025Planned publication date change to a later date
TovorafenibOralTablet217700Non-Complex09/2025Planned publication date change to a later date
TravoprostIntracameralImplant218010Complex09/2025Planned publication date change to a later date
Trospium Chloride; Xanomeline TartrateOralCapsule216158Non-Complex09/2025Planned publication date change to a later date
VadadustatOralTablet215192Non-Complex09/2025Planned publication date change to a later date
Valbenazine TosylateOralCapsule218390Non-Complex09/2025Planned publication date change to a later date
Valganciclovir HydrochlorideOralFor Solution022257Non-Complex11/2025No Change
Vonoprazan FumarateOralTablet215151Non-Complex08/2025Planned publication date change to a later date
VorasidenibOralTablet218784Non-Complex09/2025Planned publication date change to a later date

Planned Revised PSGs for Complex and Non-Complex
Generic Drug Products
Updated: July 14, 2025

Active Ingredient(s)Route Of AdministrationDosage FormRLD or RS Application NumberPlanned Revision Category with DescriptionProduct ComplexityPlanned PublicationUpdates
Copper Cu-64 DotatateIntravenousSolution213227Editorial Revision: Update the language to match Orange BookNon-Complex09/2025Newly Added
Gallium Ga-68 EdotreotideIntravenousSolution210828Editorial Revision: Update the language to match Orange BookNon-Complex09/2025Newly Added
Lutetium Lu 177 DotatateIntravenousSolution208700Editorial Revision: Update the language to match Orange BookComplex09/2025Newly Added
Neratinib MaleateOralTablet208051In Vivo Major Revision: Correct error in in vivo study design recommendation caused by a processing errorNon-Complex09/2025Newly Added
Abiraterone AcetateOralTablet202379Minor Revision: Remove recommendations on fed BE study to align with ICH M13ANon-Complex08/2025Planned publication date change to a later date
Acetaminophen; ButalbitalOralCapsule 088831Minor Revision: Remove recommendation on a strength due to safety concernsNon-Complex08/2025Planned publication date change to a later date
Aclidinium BromideInhalationPowder, Metered202450Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex09/2025Planned publication date change to a later date
Aclidinium Bromide; Formoterol FumarateInhalationPowder, Metered210595Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex09/2025Planned publication date change to a later date
Albuterol SulfateInhalationPowdered, Metered205636Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex08/2025Planned publication date change to a later date
Alectinib HydrochlorideOralCapsule208434Minor Revision: Remove recommendations on fasting BE study to align with ICH M13ANon-Complex08/2025Planned publication date change to a later date
Amantadine HydrochlorideOralCapsule, Extended Release208944Minor Revision: Remove recommendations on in vitro testNon-Complex08/2025Planned publication date change to a later date
AmbrisentanOralTablet022081Minor Revision: Remove recommendations on REMS/ETASUNon-Complex09/2025Planned publication date change to a later date
AmifampridineOralTablet208078In Vitro Major Revision: Add an in vitro study(ies)Non-Complex08/2025Planned publication date change to a later date
Amino Acids; Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Acetate; Sodium Glycerophosphate; Soybean OilIntravenousEmulsion200656Minor Revision: Remove recommendations on in vitro test; Provide more details on in vitro testing; Add recommendations for device comparisonsComplex09/2025Planned publication date change to a later date
AmphetamineOralTablet, Orally Disintegrating, Extended Release204326Minor Revision: Clarify in vitro BE studyNon-Complex09/2025Planned publication date change to a later date
Asciminib HydrochlorideOralTablet215358In Vivo Major Revision: Change in study design for in vivo BE study(ies) (to add a new higher strength)Non-Complex09/2025Planned publication date change to a later date
AspirinOralCapsule, extended release200671Minor Revision: Remove recommendations on in vitro testNon-Complex08/2025Planned publication date change to a later date
Azilsartan KamedoxomilOralTablet200796Minor Revision: Clarify in vivo study designNon-Complex08/2025Planned publication date change to a later date
Azilsartan Kamedoxomil; ChlorthalidoneOralTablet202331Minor Revision: Clarify in vivo study designNon-Complex08/2025Planned publication date change to a later date
Beclomethasone DipropionateInhalationAerosol, Metered020911Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex09/2025Planned publication date change to a later date
Beclomethasone DipropionateInhalationAerosol, Metered207921Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex09/2025Planned publication date change to a later date
Betamethasone Acetate; Betamethasone Sodium PhosphateInjectionInjectable014602Minor Revision: Clarify in vitro study design; Provide more details on in vitro testingComplex08/2025Planned publication date change to a later date
Betaxolol HydrochlorideOphthalmicSuspension/Drops019845Minor Revision: Clarify in vivo study designComplex08/2025Planned publication date change to a later date
BosentanOralTablet021290Minor Revision: Remove recommendations on REMS/ETASUNon-Complex09/2025Planned publication date change to a later date
BosentanOralTablet, for Suspension209279Minor Revision: Remove recommendations on REMS/ETASUNon-Complex09/2025Planned publication date change to a later date
Brimonidine TartrateOphthalmicSolution/Drops021770Minor Revision: Clarify in vivo study designNon-Complex08/2025Planned publication date change to a later date
Brimonidine TartrateOphthalmicSolution/Drops021262Minor Revision: Clarify in vivo study designNon-Complex08/2025Planned publication date change to a later date
Brimonidine Tartrate; BrinzolamideOphthalmicSuspension/Drops204251Minor Revision: Clarify in vivo study designComplex08/2025Planned publication date change to a later date
BrinzolamideOphthalmicSuspension/Drops020816Minor Revision: Clarify in vivo study designComplex08/2025Planned publication date change to a later date
BudesonideInhalationPowder, Metered021949Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex09/2025Planned publication date change to a later date
Buprenorphine HydrochlorideBuccalFilm207932Minor Revison: Clarify in vitro study designNon-Complex09/2025Planned publication date change to a later date
CabotegravirIntramuscularSuspension, Extended Release215499Minor Revision: Clarify in vivo study designComplex08/2025Planned publication date change to a later date
Cabotegravir; RilpivirineIntramuscularSuspension, Extended Release212888Minor Revision: Clarify in vivo study designComplex08/2025Planned publication date change to a later date
Calcitonin SalmonInjectionInjectable017808Minor Revision: Provide more details on in vitro testingComplex11/2025Planned publication date change to a later date
Carglumic AcidOralTablet, for suspension022562In Vitro Major Revision: Add an in vitro study(ies)Non-Complex08/2025Planned publication date change to a later date
CiclesonideInhalationAerosol, Metered021658Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex09/2025Planned publication date change to a later date
ClevidipineIntravenousEmulsion022156Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidancesComplex08/2025Planned publication date change to a later date
ClotrimazoleTopicalCream017619Editorial Revision: Update the languageMinor Revision: Add an in vitro  BE option Complex08/2025Planned publication date change to a later date
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil FumarateOralTablet203100Minor Revision: Remove recommendations on fasting BE study to align with ICH M13ANon-Complex08/2025Planned publication date change to a later date
CrofelemerOralTablet, Delayed Release 202292Minor Revision: Expand the eligibility for an in vitro-based BE optionComplex09/2025Planned publication date change to a later date
Cyclobenzaprine HydrochlorideOralCapsule, Extended Release021777Minor Revision: Remove recommendations on in vitro testNon-Complex08/2025Planned publication date change to a later date
Dasiglucagon HydrochlorideSubcutaneousSolution214231Minor Revision: Provide more details on in vitro testingComplex11/2025Planned publication date change to a later date
DiazepamOralTablet013263Minor Revision: Change in study design for in vivo BE study (ies)Non-Complex09/2025Planned publication date change to a later date
Dorzolamide HydrochlorideOphthalmicSolution/Drops020408Minor Revision: Clarify in vivo study designNon-Complex08/2025Planned publication date change to a later date
EpinephrineIntramuscular, SubcutaneousInjectable020800Editorial Revision: Update the languageMinor Revision: Revise recommendations for device comparisonsComplex09/2025Planned publication date change to a later date
EpinephrineIntramuscular, SubcutaneousSolution207534Editorial Revision: Update the languageMinor Revision: Revise recommendations for device comparisonsComplex09/2025Planned publication date change to a later date
EstradiolVaginalTablet020908Editorial Revision: Update the languageMinor Revision: Add an in vitro BE optionComplexWithin the next 12 monthsNo Change
Ferric DerisomaltoseIntravenousSolution208171Editorial: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidanceMinor Revision: Add in vivo BE option Complex02/2026No Change
Ferric OxyhydroxideInjectionInjectable017441Editorial: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidance; Update the language Minor Revision: Provide more details on product characterization; Provide more details on in vitro testing  Complex09/2025Planned publication date change to a later date
Ferric OxyhydroxideInjectionInjectable021135Editorial Revision: Update the languageMinor Revision: Clarify in vitro study designComplexWithin the next 12 monthsNo Change
Ferric OxyhydroxideInjectionInjectable020955Editorial: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidance; Update the language Minor Revision: Provide more details on product characterization Complex09/2025Planned publication date change to a later date
Fish Oil TriglyceridesIntravenousEmulsion210589Minor Revision: Remove recommendations on in vitro test; Provide more details on in vitro testingComplex09/2025Planned publication date change to a later date
Fish Oil; Medium Chain Triglycerides; Olive Oil; Soybean OilIntravenousEmulsion207648Minor Revision: Provide more details on product characterizationComplex09/2025Planned publication date change to a later date
Fludrocortisone AcetateOralTabletFDA-2024-P-4514Minor Revision: Add additional in vivo study design (add a new higher strength approved by suitability petition)Non-Complex09/2025Planned publication date change to a later date
FluorouracilTopicalCream020985Minor Revision: Add an in vitro BE optionComplexBeyond 12 monthsNo Change
Fluticasone FuroateInhalationPowder205625Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE optionComplex08/2025Planned publication date change to a later date
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol TrifenatateInhalationPowder209482Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE optionComplex08/2025Planned publication date change to a later date
Fluticasone Furoate; Vilanterol TrifenatateInhalationPowder204275Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE optionComplex08/2025Planned publication date change to a later date
Fluticasone PropionateInhalationPowder208798Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE optionComplex08/2025Planned publication date change to a later date
Fluticasone Propionate; Salmeterol XinafoateInhalationPowder208799Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE optionComplex08/2025Planned publication date change to a later date
Glatiramer AcetateSubcutaneousInjectable020622Minor Revision: Provide more details on product characterizationComplex08/2025Planned publication date change to a later date
GlucagonNasalPowder210134Minor Revision: Provide more details on in vitro testingComplex11/2025Planned publication date change to a later date
GlycopyrrolateInhalationPowder207923Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex09/2025Planned publication date change to a later date
Glycopyrrolate; Indacaterol MaleateInhalationPowder207930Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex09/2025Planned publication date change to a later date
Hydroxychloroquine sulfateOralTablet009768Minor Revsion: Add information on newly approved (lower or middle) strengths of the RLD/RSNon-Complex09/2025Planned publication date change to a later date
HydroxyureaOralTablet208843Minor Revision: Add BCS Class I-based biowaiver optionNon-Complex08/2025Planned publication date change to a later date
Indacaterol MaleateInhalationPowder022383Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex09/2025Planned publication date change to a later date
Ipratropium BromideInhalationAerosol, Metered021527Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex09/2025Planned publication date change to a later date
Isavuconazonium SulfateOralCapsule207500Minor Revision: Add information on newly approved (lower or middle) strengths of the RLDNon-Complex08/2025Planned publication date change to a later date
Lanreotide AcetateSubcutaneousSolution022074Editorial Revision: Update the languageMinor Revision: Add recommendations for device comparisonsComplexWithin the next 12 monthsNo Change
Lasmiditan SuccinateOralTablet211280Minor Revision: Remove recommendations on BE strengthNon-Complex08/2025Planned publication date change to a later date
LatanoprostOphthalmicEmulsion206185Minor Revision: Clarify in vivo study designComplex08/2025Planned publication date change to a later date
Levomilnacipran HydrochlorideOralCapsule, extended release204168Minor Revision: Remove recommendations on in vitro testNon-Complex08/2025Planned publication date change to a later date
LiraglutideSubcutaneousSolution022341Minor Revision: Provide more details on in vitro testingComplex11/2025No Change
LiraglutideSubcutaneousSolution206321Minor Revision: Provide more details on in vitro testingComplex11/2025No Change
Lumateperone TosylateOralCapsule209500Minor Revision: Add information on newly approved (lower or middle) strengths of the RLDNon-Complex08/2025Planned publication date change to a later date
MacitentanOralTablet204410Minor Revision: Remove recommendations on REMS/ETASUNon-Complex09/2025Planned publication date change to a later date
Macitentan; Tadalafil OralTablet218490Minor Revision: Remove recommendations on REMS/ETASUNon-Complex09/2025Planned publication date change to a later date
Medroxyprogesterone AcetateInjectionInjectable020246Minor Revision: Clarify in vitro study design; Provide more details on in vitro testingComplex08/2025Planned publication date change to a later date
Medroxyprogesterone AcetateInjectionInjectable012541Minor Revision: Add an in vitro BE optionComplex08/2025Planned publication date change to a later date
MesalamineOralTablet, Delayed Release 022000Minor Revision: Clarify in vitro study designComplex11/2025No Change
Metformin HydrochlorideOralFor Suspension, extended release212595Minor Revision: Add an in vivo BE optionNon-Complex08/2025Planned publication date change to a later date
Methylprednisolone AcetateInjectionInjectable011757Minor Revision: Clarify in vitro study design; Provide more details on in vitro testingComplex08/2025Planned publication date change to a later date
Metoprolol SuccinateOralCapsule, extended release210428Minor Revision: Remove recommendations on in vitro testNon-Complex08/2025Planned publication date change to a later date
MetronidazoleOralTablet012623Minor Revison: Clarify in vivo study designNon-Complex09/2025Planned publication date change to a later date
MetronidazoleOralCapsule020334Minor Revison: Clarify in vivo study designNon-Complex09/2025Planned publication date change to a later date
Miconazole NitrateVaginalCream 4%020827Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex08/2025Planned publication date change to a later date
Miconazole NitrateVaginalCream 2%017450Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex08/2025Planned publication date change to a later date
Minocycline HydrochlorideDentalPowder, Extended Release050781Minor Revision: Add an in vitro BE optionComplex09/2025Planned publication date change to a later date
Mometasone FuroateInhalationPowder021067Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex09/2025Planned publication date change to a later date
Naftifine HydrochlorideTopicalCream 1%019599Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex08/2025Planned publication date change to a later date
Naftifine HydrochlorideTopicalCream 2%019599Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex08/2025Planned publication date change to a later date
Naftifine HydrochlorideTopicalGel204286Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex08/2025Planned publication date change to a later date
Naftifine HydrochlorideTopicalGel019356Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex08/2025Planned publication date change to a later date
Octreotide AcetateSubcutaneousSolution213224Minor Revision: Add recommendation for device comparisonsComplex02/2026No Change
Olive Oil; Soybean OilIntravenousEmulsion204508Minor Revision: Remove recommendations on in vitro test; Provide more details on in vitro testing; Add recommendations for device comparisonsComplex09/2025Planned publication date change to a later date
Oxiconazole NitrateTopicalCream019828Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex08/2025Planned publication date change to a later date
Oxiconazole NitrateTopicalLotion020209Editorial Revision: Update the languageMinor Revision: Add an in vitro and in vivo BE option Complex08/2025Planned publication date change to a later date
PalbociclibOralTablet212436Minor Revision: Remove recommendations on fed BE study to align with ICH M13ANon-Complex09/2025Planned publication date change to a later date
Paliperidone PalmitateIntramuscularSuspension, Extended Release207946Editorial Revision: Update the language to include all relevant RLD/RS within a single PSGMinor Revision: Reorganize to include all strengths within a single PSGComplex08/2025Planned publication date change to a later date
PegcetacoplanIntravitrealSolution217171Minor Revision: Provide more details on in vitro testingComplex11/2025Planned publication date change to a later date
PegcetacoplanSubcutaneousSolution215014Minor Revision: Provide more details on in vitro testingComplex11/2025Planned publication date change to a later date
Penicillin G BenzathineInjectionInjectable050141Minor Revision: Clarify in vitro study design; Provide more details on in vitro testingComplex08/2025Planned publication date change to a later date
PerfluorohexyloctaneOphthalmicSolution216675Minor Revision: Clarify in vitro study designNon-Complex11/2025No Change
Pexidartinib HydrochlorideOralCapsule211810Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD/RSNon-Complex09/2025Planned publication date change to a later date
Phentermine Hydrochloride; TopiramateOralCapsule, Extended Release022580Minor Revision: Remove recommendations on in vitro testNon-Complex08/2025Planned publication date change to a later date
Ponatinib HydrochlorideOralTablet203469Minor Revision: Change in study design for in vivo BE study; Add information on newly approved (lower) strengths of the RLD/RSNon-Complex08/2025Planned publication date change to a later date
PosaconazoleOralSuspension022003Minor Revision: Remove recommendations on fasting BE study to align with ICH M13ANon-Complex08/2025Planned publication date change to a later date
ProgesteroneVaginalInsert022057Editorial Revision: Update the languageMinor Revision: Remove recommendations on in vivo BE option Complex08/2025Planned publication date change to a later date
Ranitidine HydrochlorideOralTablet, Effervescent020251; 020745In Vitro Major Revision: Add in vitro BE studyMinor Revision: Remove recommendation on in vivo BE studyNon-Complex08/2025Planned publication date change to a later date
RifampinOralCapsule050420Minor Revision: Reorganize to include all strengths within a single PSGNon-Complex09/2025Planned publication date change to a later date
RisperidoneIntramuscularInjectable021346Editorial Revision: Update the languageMinor Revision: Clarify in vivo study designComplex08/2025Planned publication date change to a later date
SemaglutideOralTablet213051; 213182In Vivo Major Revision: Change in study design for in vivo BE study(ies) (to add a new higher strength)Minor Revision: Provide more detail on in vitro testingNon-Complex08/2025Planned publication date change to a later date
SemaglutideSubcutaneousSolution209637Minor Revision: Provide more details on in vitro testingComplex11/2025No Change
SemaglutideSubcutaneousSolution215256Minor Revision: Provide more details on in vitro testingComplex11/2025No Change
Soybean OilInjectionInjectable017643; 018449; 020248; 019531; 019942Minor Revision: Remove recommendations on in vitro test; Provide more details on in vitro testing; Add recommendations for device comparisonsComplex09/2025Planned publication date change to a later date
SparsentanOralTablet216403Minor Revision: Remove recommendations on REMS/ETASUNon-ComplexN/ARevision no longer planned
TeriparatideSubcutaneousSolution021318Minor Revision: Provide more details on in vitro testingComplex11/2025No Change
TirzepatideSubcutaneousSolution215866Minor Revision: Provide more details on in vitro testingComplex11/2025Planned publication date change to a later date
TopiramateOralCapsule, Extended Release201635Minor Revision: Remove recommendations on in vitro testNon-Complex08/2025Planned publication date change to a later date
TopiramateOralCapsule, Extended Release205122Minor Revision: Remove recommendations on in vitro testNon-Complex08/2025Planned publication date change to a later date
TorsemideOralTablet213218Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD/RSNon-Complex08/2025Planned publication date change to a later date
Trazodone HydrochlorideOralTablet, Extended Release022411Minor Revision: Add an in vivo BE optionNon-Complex08/2025Planned publication date change to a later date
Triamcinolone AcetonideInjectionInjectable012041, 014901Minor Revision: Clarify in vitro study design; Provide more details on in vitro testingComplex08/2025Planned publication date change to a later date
Umeclidinium BromideInhalationPowder205382Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE optionComplex08/2025Planned publication date change to a later date
Umeclidinium Bromide; Vilanterol TrifenatateInhalationPowder203975Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE optionComplex08/2025Planned publication date change to a later date
Valbenazine Tosylate OralCapsule209241In Vitro Major Revision: Update in BCS waiver recommendationNon-Complex09/2025Planned publication date change to a later date
Venlafaxine HydrochlorideOralCapsule, Extended Release020699Minor Revision: Remove recommendations on in vitro testNon-Complex08/2025Planned publication date change to a later date
VosoritideSubcutaneousPowder214938Minor Revision: Provide more details on in vitro testingComplex11/2025No Change
ZonisamideOral Capsule FDA-2018-P-0098Minor Revision: Add additional in vivo study design (add a new higher strength approved by suitability petition)Non-Complex08/2025Planned publication date change to a later date

 

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