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  5. Upcoming Product-Specific Guidances for Generic Drug Product Development
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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 February 15, 2024

 

 

Active Ingredient(s) Route of Administration Dosage Form RLD or RS Application Number Product Complexity Planned Publication
Air Polymer-Type A Intrauterine Foam 212279 Complex 08/2024
Amikacin Sulfate Inhalation Suspension, Liposomal 207356 Complex 05/2024
Aripiprazole Oral Tablet 207202 Complex Within the next 12 months
Atorvastatin Calcium Oral Suspension 213260 Non-Complex 05/2024
Baclofen Oral Suspension 215602 Non-Complex 05/2024
Bexagliflozin Oral Tablet 214373 Non-Complex 05/2024
Clobetasol Propionate Topical Cream 209483 Complex Beyond 12 months
Daprodustat Oral Tablet 216951 Non-Complex 05/2024
Desmopressin Acetate Nasal Spray, Metered 201656 Complex 11/2024
Elacestrant Dihydrochloride Oral Tablet 217639 Non-Complex 05/2024
Fezolinetant Oral Tablet 216578 Non-Complex 08/2024
Fluticasone Propionate Nasal Spray, Metered 209022 Complex Beyond 12 months
Gadopiclenol Intravenous Solution 216986 Non-Complex 05/2024
Ganciclovir Ophthalmic Gel 022211 Complex 05/2024
Ganirelix Acetate Injection Injectable 021057 Non-Complex 05/2024
Gepirone Hydrochloride Oral Tablet, Extended Release 021164 Non-Complex 05/2024
Indomethacin Oral Suspension 018332 Non-Complex 05/2024
Lacosamide Oral Capsule, Extended Release 216185 Non-Complex 05/2024
Lanreotide Acetate Subcutaneous Solution 215395 Complex Within the next 12 months
Leniolisib Phosphate Oral Tablet 217759 Non-Complex 08/2024
Levodopa Inhalation Powder 209184 Complex 05/2024
Levonorgestrel Intrauterine Intrauterine Device 208224 Complex Within the next 12 months
Lidocaine Hydrochloride Ophthalmic Gel 022221 Complex 05/2024
Lidocaine; Tetracaine Topical Patch 021623 Complex Beyond 12 months
Liraglutide Recombinant Subcutaneous Solution 206321 Complex 05/2024
Lotilaner Ophthalmic Solution/Drops 217603 Non-Complex 05/2024
Magnesium Sulfate; Polyethylene Glycol 3350; Potassium Chloride; Sodium Chloride; Sodium Sulfate Oral For Solution 215344 Complex 11/2024
Mitomycin Pyelocalyceal Powder 211728 Complex Beyond 12 months
Mometasone Furoate Implantation Implant 209310 Complex 02/2025
Nalmefene Hydrochloride Nasal Spray 217470 Complex 05/2024
Naloxone Hydrochloride Nasal Spray, Metered 217722 Complex 08/2024
Nirmatrelvir; Ritonavir Oral Tablet 217188 Non-Complex 08/2024
Omaveloxolone Oral Capsule 216718 Non-Complex 05/2024
Oxazepam Oral Capsule 015539 Non-Complex 05/2024
Oxymetazoline Hydrochloride Ophthalmic Solution/Drops 212520 Non-Complex Within the next 12 months
Palovarotene Oral Capsule 215559 Non-Complex 11/2024
Patiromer Sorbitex Calcium Oral Powder 205739 Complex Within the next 12 months
Pegcetacoplan Subcutaneous Solution 215014 Complex 05/2024
Perfluorohexyloctane Ophthalmic Solution/Drops 216675 Non-Complex 05/2024
Pirtobrutinib Oral Tablet 216059 Non-Complex 05/2024
Quizartinib Dihydrochloride Oral Tablet 216993 Non-Complex 11/2024
Rezafungin Acetate Intravenous Powder 217417 Non-Complex 05/2024
Ritlecitinib Tosylate Oral Capsule 215830 Non-Complex 11/2024
Roflumilast Topical Cream 215985 Complex Within the next 12 months
Sodium Oxybate Oral For Suspension, Extended Release 214755 Non-Complex 05/2024
Sotagliflozin Oral Tablet 216203 Non-Complex 08/2024
Sparsentan Oral Tablet 216403 Non-Complex 05/2024
Tasimelteon Oral Suspension 214517 Non-Complex 05/2024
Tobramycin Inhalation Powder 201688 Complex 05/2024
Tofersen Intrathecal Solution 215887 Complex 08/2024
Treprostinil Inhalation Powder 214324 Complex 11/2024
Trofinetide Oral Solution 217026 Non-Complex 08/2024
Zavegepant Hydrochloride Nasal Spray, Metered 216386 Complex 05/2024

 

Planned Revised PSGs for Complex and Non-Complex
Generic Drug Products
Updated February 15, 2024

 

Active Ingredient(s) Route of Administration Dosage Form RLD or RS Application Number Planned Revision Category with Description Product Complexity Planned Publication
Acetaminophen; Butalbital Oral Capsule  088831 Minor Revision: Remove recommendation on a strength due to safety concerns Non-Complex Within the next 12 months
Albuterol Sulfate Inhalation Aerosol, Metered 020503, 020983, 021457 Editorial Revision: Update the language

Minor Revision: Clarify in vitro study design; Revise recommendations for device comparisons
Complex 08/2024
Albuterol Sulfate; Ipratropium Bromide Inhalation Spray, Metered 021747 Editorial Revision: Update the language

Minor Revision: Clarify in vitro study design; Revise recommendations for device comparisons
Complex 08/2024
Allopurinol Oral Tablet 016084 Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD/RS Non-Complex 08/2024
Apalutamide Oral Tablet 210951 In Vivo Major Revision: Change in study design for in vivo BE study(ies) (to add a new higher strength) Non-Complex 08/2024
Azelaic Acid Topical Cream 020428 Minor Revision: Add an in vitro BE option Complex 08/2024
Azelaic Acid Topical Gel 021470 Minor Revision: Add an in vitro BE option Complex 08/2024
Benzoyl Peroxide; Erythromycin Topical Gel 050557 Editorial Revision: Update the language

Minor Revision: Add new links or references to general guidances
Complex 05/2024
Benzoyl Peroxide; Erythromycin Topical Gel 050769 Editorial Revision: Update the language

Minor Revision: Add an in vitro BE option as an alternative BE approach
Complex 05/2024
Budesonide; Formoterol Fumarate Dihydrate Inhalation Aerosol, Metered 021929 Minor Revision: Add an in vitro and in vivo BE option Complex 02/2025
Ciprofloxacin; Dexamethasone Otic Suspension/Drops 021537 Minor Revision: Remove recommendations on in vitro microbial kill rate study; Clarify in vitro study design; Add recommendations for device comparisons Complex 05/2024
Ciprofloxacin Hydrochloride; Hydrocortisone Otic Suspension/Drops 020805 Minor Revision: Remove recommendations on in vitro microbial kill rate study; Clarify in vitro study design; Add recommendations for device comparisons Complex 05/2024
Fentanyl Citrate Nasal Spray, Metered 022569 Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Update the language

Minor Revision: Clarify in vitro and in vivo study design; Add recommendations for device comparisons
Complex 08/2024
Ferric Citrate Oral  Tablet 205874 Minor Revision: Change in study design for in vivo BE study(ies) with revised BE criteria Complex 05/2024
Fluorouracil Topical Cream 020985 Minor Revision: Add an in vitro BE option Complex Beyond 12 months
Fluticasone Furoate Inhalation Powder 205625 Editorial Revision: Update the language

Minor Revision: Clarify in vitro study design; Add recommendations for device comparisons
Complex 05/2024
Fluticasone Furoate; Vilanterol Trifenatate Inhalation Powder 204275 Editorial Revision: Update the language

Minor Revision: Clarify in vitro study design; Add recommendations for device comparison
Complex 05/2024
Fluticasone Propionate Inhalation Powder 020833 Minor Revision: Add an in vitro and in vivo BE option Complex 11/2024
Fluticasone Propionate Inhalation Aerosol, Metered  021433 Minor Revision: Add an in vitro and in vivo BE option Complex 08/2024
Fluticasone Propionate; Salmeterol Xinafoate Inhalation Aerosol, Metered 021254 Minor Revision: Add an in vitro and in vivo BE option Complex 08/2024
Fluticasone Propionate; Salmeterol Xinafoate Inhalation Powder 021077 Minor Revision: Add an in vitro and in vivo BE option Complex 11/2024
Formoterol Fumarate Inhalation Powder 020831 Minor Revision: Add an in vitro and in vivo BE option Complex 11/2024
Formoterol Fumarate; Mometasone Furoate Inhalation Aerosol, Metered 022518 Minor Revision: Add an in vitro and in vivo BE option Complex 02/2025
Halobetasol Propionate Topical Ointment 019968 Editorial Revision: Update the language

Minor Revision: Add an in vitro BE option
Complex 08/2024
Ibrutinib Oral Tablet 210563 Minor Revision: Add information on newly approved (lower or middle) strengths of the RLD/RS Non-Complex 08/2024
Lanreotide Acetate Subcutaneous Solution 022074 Editorial Revision: Update the language

Minor Revision: Add recommendations for device comparisons
Complex Within the next 12 months
Levalbuterol Tartrate Inhalation Aerosol, Metered 021730 Minor Revision: Add an in vitro and in vivo BE option Complex 08/2024
Levonorgestrel Intrauterine Intrauterine Device 203159 Minor Revision: Clarify in vivo and in vitro study designs; Add recommendations for device comparisons Complex Within the next 12 months
Mometasone Furoate Inhalation Aerosol, Metered 205641 Minor Revision: Add an in vitro and in vivo BE option Complex 02/2025
Naloxone Hydrochloride Nasal Spray, Metered 208411 Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Update the language

Minor Revision: Clarify in vitro and in vivo study design; Revise recommendations for device comparisons
Complex 08/2024
Nepafenac Ophthalmic Suspension/Drops 021862 Minor Revision: Clarify in vitro study design; Add recommendations for device comparisons Complex 05/2024
Nepafenac Ophthalmic Suspension/Drops 203491 Minor Revision: Clarify in vitro study design; Add recommendations for device comparisons Complex 05/2024
Nitrofurantoin Oral Suspension 009175 In Vivo Major Revision: Change in study design for in vivo BE study(ies) (to add a new higher strength) Non-Complex 05/2024
Olodaterol Hydrochloride Inhalation Spray, Metered 203108 Editorial Revision: Update the language

Minor Revision: Clarify in vitro study design; Revise recommendations for device comparisons
Complex 08/2024
Olodaterol Hydrochloride; Tiotropium Bromide Inhalation Spray, Metered 206756 Editorial Revision: Update the language

Minor Revision: Clarify in vitro study design; Revise recommendations for device comparisons
Complex 08/2024
Progesterone  Vaginal Insert 022057 Editorial Revision: Update the language

Minor Revision: Add additional in vivo study design; Add recommendations for device comparisons; Change in study design for in vivo BE studies
Complex 08/2024
Promethazine Hydrochloride Rectal  Suppository 010926 Editorial Revision: Update the language Complex  08/2024
Salmeterol Xinafoate Inhalation Powder 020692 Minor Revision: Add an in vitro and in vivo BE option Complex 11/2024
Tiotropium Bromide Inhalation Spray, Metered 021936 Editorial Revision: Update the language

Minor Revision: Clarify in vitro study design; Revise recommendations for device comparisons
Complex 08/2024
Tiotropium Bromide Inhalation Powder 021395 Minor Revision: Add an in vitro and in vivo BE option Complex 11/2024
Tramadol Hydrochloride Oral Tablet 020281 In Vivo Major Revision: Change in study design for in vivo BE study(ies) (to add a new higher strength) Non-Complex 08/2024
Tretinoin Topical Gel 020475 Minor Revision: Add an in vitro BE option

Editorial Revision: Update the language; Update the references
Complex 05/2024
 
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