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Upcoming Product-Specific Guidances for Complex 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 complex generic drug products.

What is a complex generic drug product?

As described in the GDUFA II Commitment Letter, 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 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 complex generic drug products, when finalized, describe FDA’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 being provided on this web page?

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

  • Major revision: A PSG is being revised to include additional bioequivalence studies or evidence recommended to support FDA approval.
  • Minor revision: Any revision that is not considered major, including but not limited to when a PSG is to be revised to remove certain studies, to provide alternative (less burdensome) approaches to the currently recommended studies, to add information on newly approved strengths of the RLD, or to make other recommendations that would not generally result in additional recommended bioequivalence studies or evidence by an ANDA applicant.
  • Editorial revision: A PSG is being revised to include 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.

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 complex generic drug products.  

New and Revised PSGs for Complex Generic Drug Products

Below is the list of PSGs for 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 complex generic drug products, it should be noted that timing may be subject to change.

 

Planned New PSGs for Complex Generic Drug Products
Updated August 20, 2021

Active Ingredient(s)

Route of Administration

Dosage Form

RLD or RS Application Number

ABAMETAPIR

TOPICAL

LOTION

206966

ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

INHALATION

POWDER, METERED

210595

ACYCLOVIR; HYDROCORTISONE

TOPICAL

CREAM

022436

AFAMELANOTIDE

SUBCUTANEOUS

IMPLANT

210797

ARIPIPRAZOLE

ORAL

TABLET

207202

ASENAPINE

TRANSDERMAL

SYSTEM

212268

BECLOMETHASONE DIPROPIONATE MONOHYDRATE

NASAL

SPRAY, METERED

019389

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

TOPICAL

CREAM

213422

CHLORHEXIDINE GLUCONATE

DENTAL

TABLET

020774

CICLESONIDE

NASAL

SPRAY, METERED

022004

CLOBETASOL PROPIONATE

TOPICAL

CREAM

209483

COLESEVELAM HYDROCHLORIDE

ORAL

BAR, CHEWABLE

210895

CYTARABINE; DAUNORUBICIN

INTRAVENOUS

POWDER

209401

DESMOPRESSIN ACETATE

NASAL

SPRAY, METERED

201656

DOXYCYCLINE HYCLATE

PERIODONTAL

SYSTEM, EXTENDED RELEASE

050751

ETELCALCETIDE

INTRAVENOUS

SOLUTION

208325

ETHINYL ESTRADIOL; SEGESTERONE ACETATE

VAGINAL

RING

209627

ETONOGESTREL

IMPLANTATION

IMPLANT

021529

EXENATIDE

SUBCUTANEOUS

SUSPENSION, EXTENDED RELEASE

209210

EXENATIDE SYNTHETIC

SUBCUTANEOUS

FOR SUSPENSION, EXTENDED RELEASE

022200

FERRIC DERISOMALTOSE

INTRAVENOUS

SOLUTION

208171

FIDAXOMICIN

ORAL

FOR SUSPENSION

213138

FLUNISOLIDE

NASAL

SPRAY, METERED

018148

FLUOROURACIL

TOPICAL

CREAM

022259

FLUTICASONE PROPIONATE

NASAL

SPRAY, METERED

209022

FORMOTEROL FUMARATE; GLYCOPYRROLATE

INHALATION

AEROSOL, METERED

208294

GLUCAGON

SUBCUTANEOUS

SOLUTION

212097

GOLODIRSEN

INTRAVENOUS

SOLUTION

211970

HALOBETASOL PROPIONATE

TOPICAL

AEROSOL, FOAM

210566

HALOBETASOL PROPIONATE

TOPICAL

LOTION

209355

HEPARIN SODIUM

INJECTION

INJECTABLE

017029

HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE

TOPICAL

AEROSOL, FOAM

086457

IRINOTECAN HYDROCHLORIDE

INTRAVENOUS

INJECTABLE, LIPOSOMAL

207793

LEUPROLIDE ACETATE

SUBCUTANEOUS

POWDER

021379; 021488

LEUPROLIDE ACETATE

SUBCUTANEOUS

POWDER

021731; 213150

LEVODOPA

INHALATION

POWDER

209184

LEVONORGESTREL

INTRAUTERINE

INTRAUTERINE DEVICE

208224

LIDOCAINE; TETRACAINE

TOPICAL

PATCH

021623

MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE

ORAL

TABLET

213135

MECHLORETHAMINE HYDROCHLORIDE

TOPICAL

GEL

202317

MICONAZOLE NITRATE; PETROLATUM, WHITE; ZINC OXIDE

TOPICAL

OINTMENT

021026

MOMETASONE FUROATE

IMPLANTATION

IMPLANT

209310

NUSINERSEN SODIUM

INTRATHECAL

SOLUTION

209531

PATIROMER SORBITEX CALCIUM

ORAL

POWDER

205739

PROGESTERONE

VAGINAL

SYSTEM

201110

SECRETIN SYNTHETIC HUMAN

INTRAVENOUS

FOR SOLUTION

021256

SODIUM CHLORIDE

INHALATION

AEROSOL, METERED

019912

TEGASEROD MALEATE

ORAL

TABLET

021200

TENAPANOR HYDROCHLORIDE

ORAL

TABLET

211801

TOBRAMYCIN

INHALATION

POWDER

201688

ZANAMIVIR

INHALATION

POWDER

021036

 

Planned Revised PSGs for Complex Generic Drug Products
Updated August 20, 2021

Active Ingredient(s)

Route of Administration

Dosage Form

RLD or RS Application Number

Planned Revision Category (Brief Reason)

ACARBOSE

ORAL

TABLET

020482

Minor Revision: Change the study design for in vivo BE studies

ACYCLOVIR

TOPICAL

CREAM

021478

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance; Expand the eligibility for an in vitro-based BE option; Comply with Clinical Data Interchange Standards Consortium (CDISC)

ACYCLOVIR

TOPICAL

OINTMENT

018604

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance; Expand the eligibility for an in vitro-based BE option

ADAPALENE; BENZOYL PEROXIDE

TOPICAL

GEL

022320

Editorial Revision:  Update the language

 

Minor Revision: Add an in vitro BE option as an alternative BE approach

ADAPALENE; BENZOYL PEROXIDE

TOPICAL

GEL

207917

Editorial Revision:  Update the language

 

Minor Revision: Add an in vitro BE option as an alternative BE approach

BENZYL ALCOHOL

TOPICAL

LOTION

022129

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance; Expand the eligibility for an in vitro-based BE option; Comply with CDISC

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

TOPICAL

OINTMENT

021852

Editorial Revision:  Correct typos; Update the language

 

Minor Revision: Add an in vitro BE option as an alternative BE approach

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

TOPICAL

SUSPENSION

022185

Editorial Revision:  Correct typos; Update the language

 

Minor Revision: Add an in vitro BE option as an alternative BE approach

BEXAROTENE

TOPICAL

GEL

021056

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance; Expand the eligibility for an in vitro-based BE option

BUTENAFINE HYDROCHLORIDE

TOPICAL

CREAM

020524

Editorial Revision:  Update the language

 

Minor Revision: Add an in vitro BE option as an alternative BE approach

BUTENAFINE HYDROCHLORIDE

TOPICAL

CREAM

021307

Editorial Revision:  Update the language

 

Minor Revision: Add an in vitro BE option as an alternative BE approach

CALCIPOTRIENE

TOPICAL

OINTMENT

020273

Editorial Revision:  Update the language

 

Minor Revision: Add an in vitro BE option as an alternative BE approach

CALCIPOTRIENE

TOPICAL

CREAM

020554

Editorial Revision:  Update the language

 

Minor Revision: Add an in vitro BE option as an alternative BE approach

CLINDAMYCIN PHOSPHATE

TOPICAL

GEL

050615

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

CLINDAMYCIN PHOSPHATE

TOPICAL

GEL

050782

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

CLINDAMYCIN PHOSPHATE

TOPICAL

 LOTION

050600

Editorial Revision:  Update the language

 

Minor Revision: Add an in vitro BE option as an alternative BE approach

CLINDAMYCIN PHOSPHATE; TRETINOIN

TOPICAL

GEL

050802

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

CLINDAMYCIN PHOSPHATE; TRETINOIN

TOPICAL

GEL

050803

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

COLESEVELAM HYDROCHLORIDE

ORAL

TABLET

021176

Minor Revision: Provide more details on product characterization

COLESEVELAM HYDROCHLORIDE

ORAL

FOR SUSPENSION

022362

Minor Revision: Provide more details on product characterization

CRISABOROLE

TOPICAL

OINTMENT

207695

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance; Expand the eligibility for an in vitro-based BE option; Comply with CDISC

CROTAMITON

TOPICAL

CREAM

006927

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add links or references to general guidance

CROTAMITON

TOPICAL

LOTION

009112

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add links or references to general guidance

DAPSONE

TOPICAL

GEL

207154

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

DAPSONE

TOPICAL

GEL

021794

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

DAUNORUBICIN CITRATE

INJECTION

INJECTABLE, LIPOSOMAL

050704

Editorial Revision: Correct typos

DICLOFENAC SODIUM

TOPICAL

GEL

021005

Editorial Revision:  Update the language

 

Minor Revision: Add an in vitro BE option as an alternative BE approach

DICLOFENAC SODIUM

TOPICAL

GEL

022122

Editorial Revision:  Update the language; Update the web links

 

Minor Revision: Add an in vitro BE option as an alternative BE approach; Comply with CDISC

DOCOSANOL

TOPICAL

CREAM

020941

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance; Expand the eligibility for an in vitro-based BE option; Comply with CDISC

DOXEPIN HYDROCHLORIDE

TOPICAL

CREAM

020126

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

ERYTHROMYCIN

TOPICAL

GEL

050617

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add links or references to general guidance

FERRIC OXYHYDROXIDE

(Previous active ingredient name: Iron Dextran)

INJECTION

INJECTABLE

017441

Editorial Revision: Update the active ingredient name

 

Minor Revision: Provide more details on product characterization; Add additional in vivo study design option

FERRIC OXYHYDROXIDE

(Previous active ingredient name: Sodium Ferric Gluconate Complex)

INJECTION

INJECTABLE

020955

Editorial Revision: Update the active ingredient name

 

Minor Revision: Provide more details on product characterization; Add additional in vivo study design option

FERRIC OXYHYDROXIDE

(Previous active ingredient name: IRON SUCROSE)

INTRAVENOUS

INJECTABLE

021135

Editorial Revision: Update the active ingredient name

 

Minor Revision:  Provide more details on product characterization; Add additional in vivo study design option

FERRIC OXYHYDROXIDE

(Previous active ingredient name: Sucroferric Oxyhydroxide)

ORAL

TABLET, CHEWABLE

205109

Editorial Revision: Update the active ingredient name

 

Minor Revision:  Clarify in vitro study design

FLUOCINOLONE ACETONIDE

TOPICAL

CREAM

012787

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add links or references to general guidance

FLUOROURACIL

TOPICAL

CREAM

016831

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add an in vitro BE option as an alternative BE approach

FLUOROURACIL

TOPICAL

CREAM

020985

Minor Revision: Add an in vitro BE option as an alternative BE approach

FLUOROURACIL

TOPICAL

CREAM

016988

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add an in vitro BE option as an alternative BE approach

GENTAMICIN SULFATE

TOPICAL

CREAM

062307

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add links or references to general guidance

GENTAMICIN SULFATE

TOPICAL

OINTMENT

062351

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add links or references to general guidance

HYDROCORTISONE

TOPICAL

CREAM

089414

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add links or references to general guidance

IVERMECTIN

TOPICAL

CREAM

206255

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance; Expand the eligibility for an in vitro-based BE option

IVERMECTIN

TOPICAL

LOTION

202736

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance; Expand the eligibility for an in vitro-based BE option; Comply with CDISC

LEUPROLIDE ACETATE

IMPLANTATION

IMPLANT

021088

Minor Revision:  Clarify in vivo study design

LEUPROLIDE ACETATE; NORETHINDRONE ACETATE

INTRAMUSCULAR, ORAL

INJECTABLE, TABLET

203696

Minor Revision:  Clarify in vivo study design

LEVONORGESTREL

INTRAUTERINE

INTRAUTERINE DEVICE

203159

Minor Revision: Clarify in vitro and in vivo BE study designs

LIDOCAINE

TOPICAL

OINTMENT

008048

Minor Revision: Clarify in vitro study design; Add links or references to general guidance

LIDOCAINE

TOPICAL

PATCH

207962

Minor Revision: Change study design for in vivo BE studies

LULICONAZOLE

TOPICAL

CREAM

204153

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance; Expand the eligibility for an in vitro-based BE option; Comply with CDISC

METHYLPREDNISOLONE ACETATE

INJECTION

INJECTABLE

011757

Editorial Revision: Update the language

 

Minor Revision: Add an in vitro BE option as an alternative BE approach

METRONIDAZOLE

TOPICAL

CREAM

020531

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

METRONIDAZOLE

TOPICAL

CREAM

020743

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

METRONIDAZOLE

TOPICAL

GEL 0.75%

019737

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

METRONIDAZOLE

TOPICAL

GEL 1%

021789

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

METRONIDAZOLE

VAGINAL

GEL

205223

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

METRONIDAZOLE

TOPICAL

LOTION

020901

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

METRONIDAZOLE

VAGINAL

GEL

020208; 021806

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

MUPIROCIN CALCIUM

TOPICAL

CREAM

050746

Editorial Revision:  Update the language

 

Minor Revision: Add an in vitro BE option as an alternative BE approach; Comply with CDISC

NYSTATIN

TOPICAL

CREAM

064022

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add links or references to general guidance

NYSTATIN

TOPICAL

OINTMENT

062124

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add links or references to general guidance

NYSTATIN; TRIAMCINOLONE ACETONIDE

TOPICAL

CREAM

062364

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add links or references to general guidance

NYSTATIN; TRIAMCINOLONE ACETONIDE

TOPICAL

OINTMENT

063305

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add links or references to general guidance

OXYCODONE

ORAL

CAPSULE, EXTENDED RELEASE

208090

Major Revision: Add additional in vitro feeding tube studies

OXYMETAZOLINE HYDROCHLORIDE

TOPICAL

CREAM

208552

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

OZENOXACIN

TOPICAL

CREAM

208945

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance; Expand the eligibility for an in vitro-based BE option; Comply with CDISC

PENCICLOVIR

TOPICAL

CREAM

020629

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance; Expand the eligibility for an in vitro-based BE option

PIMECROLIMUS

TOPICAL

CREAM

021302

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

RIFAXIMIN

ORAL

TABLET

021361; 022554

Major Revision: Add in vivo BE study

SILVER SULFADIAZINE

TOPICAL

CREAM

017381

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance; Expand the eligibility for an in vitro-based BE option

SPINOSAD

TOPICAL

SUSPENSION

022408

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance; Expand the eligibility for an in vitro-based BE option; Comply with CDISC

TACROLIMUS

TOPICAL

OINTMENT 0.03%

050777

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance; Expand the eligibility for an in vitro-based BE option; Comply with CDISC

TACROLIMUS

TOPICAL

OINTMENT 0.1%

050777

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance; Expand the eligibility for an in vitro-based BE option; Comply with CDISC

TAZAROTENE

TOPICAL

GEL 0.05%

020600

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add an in vitro BE option as an alternative BE approach

TAZAROTENE

TOPICAL

GEL  0.1%

020600

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add an in vitro BE option as an alternative BE approach

TESTOSTERONE

IMPLANTATION

PELLET

080911

Major Revision: Add additional partial AUC recommendations

TRETINOIN

TOPICAL

GEL

017955

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

TRETINOIN

TOPICAL

GEL

017579

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

TRETINOIN

TOPICAL

GEL

022070

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances; Reorganize information on physicochemical and structural characterization studies

 

Minor Revision: Add links or references to general guidance

TRIAMCINOLONE ACETONIDE

INJECTION

INJECTABLE

012041; 014901

Editorial Revision: Correct typos

 

Minor Revision: Add information on newly approved strengths of the RLD

TRIAMCINOLONE ACETONIDE

TOPICAL

CREAM

011601

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add links or references to general guidance

TRIAMCINOLONE ACETONIDE

TOPICAL

OINTMENT 0.025%, 0.1%, 0.5%

087385

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add links or references to general guidance

TRIAMCINOLONE ACETONIDE

TOPICAL

OINTMENT

089595

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add links or references to general guidance

TRIAMCINOLONE ACETONIDE

TOPICAL

LOTION

011602

Editorial Revision: Harmonize the language for BE recommendations across similar PSGs in alignment with the general guidances

 

Minor Revision: Add links or references to general guidance

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