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: November 19, 2024
| Active Ingredient(s) | Route of Administration | Dosage Form | RLD or RS Application Number | Product Complexity | Planned Publication | Updates |
|---|---|---|---|---|---|---|
| Abiraterone Acetate; Niraparib Tosylate | Oral | Tablet | 216793 | Non-Complex | 05/2025 | Newly Added |
| Albuterol Sulfate; Budesonide | Inhalation | Aerosol, Metered | 214070 | Complex | 02/2025 | No Change |
| Amikacin Sulfate | Inhalation | Suspension, Liposomal | 207356 | Complex | Beyond 12 months | No Change |
| Aprocitentan | Oral | Tablet | 217686 | Non-Complex | 08/2025 | No Change |
| Arimoclomol | Oral | Capsule | 214927 | Non-Complex | 11/2025 | Newly Added |
| Aripiprazole | Oral | Tablet | 207202 | Complex | Within the next 12 months | No Change |
| Benzgalantamine Gluconate | Oral | Tablet, Delayed Release | 218549 | Non-Complex | 02/2025 | Newly Added |
| Brimonidine Tartrate | Ophthalmic | Solution/Drops | 218424 | Non-Complex | 02/2025 | No Change |
| Budesonide | Oral | Suspension | 213976 | Complex | 08/2025 | Newly Added |
| Budesonide; Formoterol Fumarate | Inhalation | Aerosol, Metered | 216579 | Complex | 02/2025 | No Change |
| Buprenorphine | Subcutaneous | Solution, Extended Release | 210136 | Complex | 05/2025 | Newly Added |
| Capivasertib | Oral | Tablet | 218197 | Non-Complex | 05/2025 | No Change |
| Carbinoxamine Maleate | Oral | Orally Disintegrating Tablet | 008955 | Non-Complex | 02/2025 | Newly Added |
| Ceftobiprole Medocaril Sodium | Intravenous | Powder | 218275 | Non-Complex | 02/2025 | No Change |
| Cephalexin | Oral | Tablet | 063024 | Non-Complex | Within the next 12 months | Planned publication date change to a later date |
| Clobetasol Propionate | Topical | Cream | 209483 | Complex | Beyond 12 months | No Change |
| Clobetasol Propionate | Ophthalmic | Suspension/Drops | 218158 | Complex | 02/2025 | No Change |
| Clonidine Hydrochloride | Oral | Suspension, Extended Release | 217645 | Non-Complex | 02/2025 | Newly Added |
| Crizotinib | Oral | Capsule, Pellets | 217581 | Non-Complex | 05/2025 | Newly Added |
| Danicopan | Oral | Tablet | 218037 | Non-Complex | 08/2025 | No Change |
| Desmopressin Acetate | Nasal | Spray, Metered | 201656 | Complex | 11/2025 | No Change |
| Diazepam | Buccal | Film | 218623 | Non-Complex | 02/2025 | Newly Added |
| Elafibranor | Oral | Tablet | 218860 | Non-Complex | 11/2025 | Newly Added |
| Ensifentrine | Inhalation | Suspension | 217389 | Complex | 05/2025 | No Change |
| Epinephrine | Intravenous | Solution | 215875 | Non-Complex | 02/2025 | No Change |
| Epinephrine | Nasal | Spray | 214697 | Complex | 02/2025 | Newly Added |
| Etrasimod Arginine | Oral | Tablet | 216956 | Non-Complex | 02/2025 | No Change |
| Flunisolide | Inhalation | Aerosol, Metered | 021247 | Complex | 08/2025 | No Change |
| Fluticasone Propionate | Nasal | Spray, Metered | 209022 | Complex | Within the next 12 months | Planned publication date assigned |
| Fruquintinib | Oral | Capsule | 217564 | Non-Complex | 05/2025 | No Change |
| Gepirone Hydrochloride | Oral | Tablet, Extended Release | 021164 | Non-Complex | 02/2025 | Planned publication date assigned |
| Givinostat Hydrochloride | Oral | Suspension | 217865 | Non-Complex | 08/2025 | No Change |
| Ibrutinib | Oral | Suspension | 217003 | Non-Complex | 05/2025 | Newly Added |
| Iptacopan Hydrochloride | Oral | Capsule | 218276 | Non-Complex | 02/2025 | Planned publication date change to an earlier date |
| Lanreotide Acetate | Subcutaneous | Solution | 215395 | Complex | Within the next 12 months | No change |
| Levacetylleucine | Oral | Suspension | 219132 | Non-Complex | 11/2025 | Newly Added |
| Levoketoconazole | Oral | Tablet | 214133 | Non-Complex | 02/2025 | Newly Added |
| Levonorgestrel | Intrauterine | Intrauterine Device | 208224 | Complex | 02/2025 | Planned publication date assigned |
| Lidocaine; Tetracaine | Topical | Patch | 021623 | Complex | Beyond 12 months | No Change |
| Melphalan Hydrochloride | Intra-Arterial | Powder | 201848 | Complex | 02/2025 | Newly Added |
| Metformin Hydrochloride | Oral | Tablet, chewable | 020357 Dosage Form is subject of approved suitability petitions (FDA-2011-P-0558) |
Non-Complex | 02/2025 | Newly Added |
| Momelotinib Dihydrochloride | Oral | Tablet | 216873 | Non-Complex | 02/2025 | No Change |
| Mometasone Furoate | Implantation | Implant | 209310 | Complex | 02/2025 | No Change |
| Motixafortide Acetate | Subcutaneous | Powder | 217159 | Non-Complex | 02/2025 | No Change |
| Naloxone Hydrochloride | Nasal | Spray | 215487 | Complex | 05/2025 | No Change |
| Nicotine | Oral | Inhalant | 020714 | Complex | 11/2025 | Newly Added |
| Nirogacestat Hydrobromide | Oral | Tablet | 217677 | Non-Complex | 05/2025 | No Change |
| Norgestrel | Oral | Tablet | 017031 | Non-Complex | 02/2025 | Newly Added |
| Paclitaxel | Intravenous | Powder | 211875 | Complex | 02/2025 | No Change |
| Patiromer Sorbitex Calcium | Oral | Powder | 205739 | Complex | Within the next 12 months | No change |
| Pemetrexed Disodium | Intravenous | Solution | 214218 | Non-Complex | 02/2025 | No Change |
| Pemetrexed Ditromethamine | Intravenous | Powder | 208746 | Non-Complex | 02/2025 | No Change |
| Pilocarpine Hydrochloride | Ophthalmic | Solution | 217836 | Non-Complex | 02/2025 | No Change |
| Repotrectinib | Oral | Capsule | 218213 | Non-Complex | 02/2025 | No Change |
| Resmetirom | Oral | Tablet | 217785 | Non-Complex | 08/2025 | No Change |
| Risperidone | Intramuscular | For Suspension, Extended Release | 214835 | Complex | 02/2025 | Newly Added |
| Roflumilast | Topical | Cream | 215985 | Complex | Within the next 12 months | No change |
| Sapropterin Dihydrochloride | Oral | Powder | 205065 | Non-Complex | 05/2025 | Newly Added |
| Selenium Sulfide | Topical | Lotion/Shampoo | 007936 | Complex | 02/2025 | Newly Added |
| Tenapanor Hydrochloride | Oral | Tablet | 213931 | Complex | 08/2025 | No Change |
| Terbinafine | Topical | Gel | 021958 | Complex | 02/2025 | Newly Added |
| Terbinafine Hydrochloride | Topical | Solution | 021124 | Non-Complex | 02/2025 | Newly Added |
| Terbinafine Hydrochloride | Topical | Spray | 021124 | Non-Complex | 02/2025 | Newly Added |
| Tovorafenib | Oral | For Suspension | 218033 | Non-Complex | 08/2025 | No Change |
| Valbenazine Tosylate | Oral | Capsule | 218390 | Non-Complex | 08/2025 | Newly Added |
| Vamorolone | Oral | Suspension | 215239 | Non-Complex | 02/2025 | No Change |
| Zilucoplan Sodium | Subcutaneous | Solution | 216834 | Non-Complex | 02/2025 | No Change |
| Zonisamide | Oral | Suspension | 214273 | Non-Complex | 02/2025 | Newly Added |
| Zuranolone | Oral | Capsule | 217369 | Non-Complex | 02/2025 | No change |
Planned Revised PSGs for Complex and Non-Complex
Generic Drug Products
Updated: November 19, 2024
| Active Ingredient(s) | Route Of Administration | Dosage Form | RLD or RS Application Number | Planned Revision Category with Description | Product Complexity | Planned Publication | Updates |
|---|---|---|---|---|---|---|---|
| Acetaminophen; Butalbital | Oral | Capsule | 088831 | Minor Revision: Remove recommendation on a strength due to safety concerns | Non-Complex | Within the next 12 months | No change |
| Aclidinium Bromide | Inhalation | Powder, Metered | 202450 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | No change |
| Aclidinium Bromide; Formoterol Fumarate | Inhalation | Powder, Metered | 210595 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | No change |
| Albuterol Sulfate | Inhalation | Powder, Metered | 205636 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 05/2025 | No Change |
| Aripiprazole | Intramuscular | For Suspension, Extended Release | 202971 | Minor Revision: Add additional in vivo study design | Complex | 02/2025 | Newly added |
| Beclomethasone Dipropionate | Inhalation | Aerosol, Metered | 020911 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | No Change |
| Beclomethasone Dipropionate | Inhalation | Aerosol, Metered | 207921 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | No change |
| Budesonide | Inhalation | Powder, Metered | 021949 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | Newly added |
| Ciclesonide | Inhalation | Aerosol, Metered | 021658 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | No change |
| Deutetrabenazine | Oral | Tablet, Extended Release | 216354 | In Vivo Major Revision: Change in study design for in vivo BE study(ies) (to add a new higher strength) Minor Revision: Add information on newly approved (middle) strengths of the RLD/RS |
Non-Complex | 02/2025 | Newly added |
| Epinephrine | Intramuscular, Subcutaneous | Solution | 207534 | Editorial Revision: Update the language Minor Revision: Revise recommendations for device comparisons |
Complex | 05/2025 | Newly added |
| Epinephrine | Intramuscular, Subcutaneous | Injectable | 020800 | Editorial Revision: Update the language Minor Revision: Revise recommendations for device comparisons |
Complex | 05/2025 | Newly added |
| Epinephrine | Inhalation | Aerosol, Metered | 205920 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 02/2025 | No Change |
| Fluticasone Furoate | Inhalation | Powder | 205625 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 05/2025 | No change |
| Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | Inhalation | Powder | 209482 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 05/2025 | Newly added |
| Fluorouracil | Topical | Cream | 020985 | Minor Revision: Add an in vitro BE option | Complex | Beyond 12 months | No change |
| Fluticasone Furoate; Vilanterol Trifenatate | Inhalation | Powder | 204275 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 05/2025 | No change |
| Fluticasone Propionate | Inhalation | Powder | 208798 | Minor Revision: Add an in vitro and in vivo BE option Editorial Revision: Update the language |
Complex | 05/2025 | Newly added |
| Fluticasone Propionate; Salmeterol Xinafoate | Inhalation | Powder | 208799 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 05/2025 | Newly added |
| Glycopyrrolate | Inhalation | Powder | 207923 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | No change |
| Glycopyrrolate; Indacaterol Maleate | Inhalation | Powder | 207930 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | No change |
| Hydroxyurea | Oral | Tablet | 208843 | Minor revision: Add BCS Class I-based biowaiver option | Non-Complex | 05/2025 | Newly added |
| Indacaterol Maleate | Inhalation | Powder | 022383 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | No change |
| Ipratropium Bromide | Inhalation | Aerosol, Metered | 021527 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | No change |
| Lanreotide Acetate | Subcutaneous | Solution | 022074 | Editorial Revision: Update the language Minor Revision: Add recommendations for device comparisons |
Complex | Within the next 12 months | No change |
| Migalastat Hydrochloride | Oral | Capsule | 208623 | Minor revision: Add BCS Class III-based biowaiver option | Non-Complex | 02/2025 | Newly added |
| Mometasone Furoate | Inhalation | Powder | 021067 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 08/2025 | Newly added |
| Ranitidine Hydrochloride | Oral | Tablet, Effervescent | 020745, 020251 | Minor Revision: Add an in vitro BE option | Non-Complex | 05/2025 | Newly added |
| Terbinafine Hydrochloride | Topical | Cream | 020980 | Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Update the references Minor Revision: Add an in vitro BE option |
Complex | 02/2025 | Newly added |
| Tipiracil Hydrochloride; Trifluridine | Oral | Tablet | 207981 | Minor revision: Add BCS Class III-based biowaiver option | Non-Complex | 02/2025 | Newly added |
| Trientine Hydrochloride | Oral | Capsule | 19194 | Minor revision: Add BCS Class III-based biowaiver option | Non-Complex | 02/2025 | Newly added |
| Umeclidinium Bromide | Inhalation | Powder | 205382 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 05/2025 | No change |
| Umeclidinium Bromide; Vilanterol Trifenatate | Inhalation | Powder | 203975 | Editorial Revision: Update the language Minor Revision: Add an in vitro and in vivo BE option |
Complex | 05/2025 | No change |
Planned Revised PSGs for Complex and Non-Complex Generic Drug Products to Align with ICH M13A
Updated: November 19, 2024
In addition to removing the BE recommendations for BE studies under either fasting or fed conditions as indicated in the table, these PSGs may also include editorial revisions to language and formatting as deemed appropriate by the Agency. Please note that for some PSGs published in October 2024, FDA has updated revisions as shown in the table below.
| Active Ingredient(s) | Route of Administration | Dosage Form | RLD or RS Application Number | Planned Revision Category with Description | Product Complexity | Planned Publication | Modifications from the Planned Revisions in the PSGs Published on Oct 30, 2024 |
|---|---|---|---|---|---|---|---|
| Amitriptyline Hydrochloride | Oral | Tablet | 012703 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Amoxicillin; Clavulanate Potassium | Oral | For Suspension | 050575 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
| Amoxicillin; Clavulanate Potassium | Oral | Tablet, Chewable | 050597 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
| Amoxicillin; Clavulanate Potassium | Oral | Tablet, Chewable | 050726 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
| Amoxicillin; Clavulanate Potassium | Oral | Tablet | 050564; 050720 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
| Amoxicillin; Clavulanate Potassium | Oral | For Suspension | 050725; 050755 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
| Bupropion Hydrochloride | Oral | Tablet | 018644 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Celecoxib | Oral | Capsule | 020998 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 02/2025 | N/A |
| Glipizide | Oral | Tablet | 017783 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
| Cevimeline Hydrochloride | Oral | Capsule | 020989 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Clomipramine Hydrochloride | Oral | Capsule | 019906 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Daridorexant Hydrochloride | Oral | Tablet | 214985 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 02/2025 | N/A |
| Dexmethylphenidate Hydrochloride | Oral | Tablet | 021278 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Donepezil Hydrochloride | Oral | Tablet | 022568 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Ertugliflozin | Oral | Tablet | 209803 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 02/2025 | N/A |
| Guanfacine Hydrochloride | Oral | Tablet | 019032 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Letrozole | Oral | Tablet | 020726 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Linagliptin; Metformin Hydrochloride | Oral | Tablet | 201281 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
| Lofexidine Hydrochloride | Oral | Tablet | 209229 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Loratadine | Oral | Capsule | 21952 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 02/2025 | N/A |
| Mexiletine Hydrochloride | Oral | Capsule | 018873 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Moxifloxacin Hydrochloride | Oral | Tablet | 021085 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Naltrexone Hydrochloride | Oral | Tablet | 018932 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Oseltamivir Phosphate | Oral | For Suspension | 021246 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class III-based biowaiver option |
| Oxybutynin Chloride | Oral | Tablet | 017577 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Oxycodone Hydrochloride | Oral | Tablet | 021011 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Promethazine Hydrochloride | Oral | Tablet | 007935 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Prucalopride Succinate | Oral | Tablet | 210166 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Selegiline Hydrochloride | Oral | Capsule | 020647 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | Published 10/2024 | The dosage form is corrected to correspond with the respective RLD. |
| Selegiline Hydrochloride | Oral | Tablet, Orally Disintegrating | 021479 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | The dosage form is corrected to correspond with the respective RLD. |
| Sildenafil Citrate | Oral | For Suspension | 203109 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
| Sildenafil Citrate | Oral | Tablet | 020895; 021845 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
| Sitagliptin Phosphate | Oral | Tablet | 021995 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Tasimelteon | Oral | Suspension | 214517 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Editorial revision. Revised PSG continues to recommend one fasting BE study. |
| Thalidomide | Oral | Capsule | 20785 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 02/2025 | N/A |
| Timolol Maleate | Oral | Tablet | 018017 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Tizanidine Hydrochloride | Oral | Capsule | 021447 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 02/2025 | N/A |
| Tolterodine Tartrate | Oral | Tablet | 020771 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Torsemide | Oral | Tablet | 213218 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Editorial revision. The revised PSG continues to recommend both fasting and fed BE studies. |
| Ursodiol | Oral | Tablet | 020675 | Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
| Valbenazine Tosylate | Oral | Capsule | 209241 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | Published 10/2024 | Additional Minor revision: Added BCS Class I-based biowaiver option |
| Verapamil Hydrochloride | Oral | Tablet | 018593; 018817 | Minor Revision: Remove recommendations on fed BE study to align with ICH M13A | Non-Complex | 02/2025 | N/A |