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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 November 18, 2020

Active Ingredient(s)

Route of Administration

Dosage Form

RLD Application Number

ACYCLOVIR

OPHTHALMIC

OINTMENT

202408

ACYCLOVIR; HYDROCORTISONE

TOPICAL

CREAM

022436

AFAMELANOTIDE

SUBCUTANEOUS

IMPLANT

210797

BREMELANOTIDE ACETATE

SUBCUTANEOUS

SOLUTION

210557

CHLORHEXIDINE GLUCONATE

DENTAL

TABLET

020774

CLOBETASOL PROPIONATE

TOPICAL

CREAM

209483

COLESEVELAM HYDROCHLORIDE

ORAL

BAR, CHEWABLE

210895

COPPER DOTATATE CU-64

INTRAVENOUS

SOLUTION

213227

CYTARABINE; DAUNORUBICIN

INTRAVENOUS

POWDER

209401

DEGARELIX ACETATE

SUBCUTANEOUS

POWDER

022201

DESMOPRESSIN ACETATE

NASAL

SPRAY, METERED

201656

DOXYCYCLINE HYCLATE

PERIODONTAL

SYSTEM, EXTENDED RELEASE

050751

ETHINYL ESTRADIOL; SEGESTERONE ACETATE

VAGINAL

RING

209627

EXENATIDE

SUBCUTANEOUS

SUSPENSION, EXTENDED RELEASE

209210

FERRIC DERISOMALTOSE

INTRAVENOUS

SOLUTION

208171

FIDAXOMICIN

ORAL

FOR SUSPENSION

213138

FLUOROURACIL

TOPICAL

CREAM

022259

FLUTICASONE PROPIONATE

NASAL

SPRAY, METERED

209022

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

021343

LEUPROLIDE ACETATE

SUBCUTANEOUS

 Powder

021731

LEVODOPA

INHALATION

POWDER

209184

LEVONORGESTREL

INTRAUTERINE

INTRAUTERINE DEVICE

208224

LIDOCAINE; TETRACAINE

TOPICAL

PATCH

021623

LOTEPREDNOL ETABONATE

OPHTHALMIC

GEL

208219

MECHLORETHAMINE HYDROCHLORIDE

TOPICAL

GEL

202317

MELOXICAM

INTRAVENOUS

SOLUTION

210583

MICONAZOLE NITRATE; PETROLATUM, WHITE; ZINC OXIDE

TOPICAL

OINTMENT

021026

MIDAZOLAM

NASAL

SPRAY

211321

MOMETASONE FUROATE

IMPLANTATION

IMPLANT

209310

OCTREOTIDE ACETATE

SUBCUTANEOUS

SOLUTION

213224

OLODATEROL HCL; TIOTROPIUM BROMIDE

INHALATION

SPRAY; METERED

206756

PATIROMER SORBITEX CALCIUM

ORAL

POWDER

205739

PENICILLIN G BENZATHINE

INJECTION

INJECTABLE

050141

PROGESTERONE

VAGINAL

SYSTEM

201110

SECRETIN SYNTHETIC HUMAN

INTRAVENOUS

FOR SOLUTION

021256

SEMAGLUTIDE

ORAL

TABLET

213051

TENAPANOR HYDROCHLORIDE

ORAL

TABLET

211801

TOBRAMYCIN

INHALATION

POWDER

201688

 

 

 

 

Planned Revised PSGs for Complex Generic Drug Products
Updated November 18, 2020

Active Ingredient(s)

Route of Administration

Dosage Form

RLD Application Number

Planned Revision Category (Brief Reason)

ACYCLOVIR

TOPICAL

CREAM

021478

Editorial Revision: Reorganize information on In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT); Update the language

Minor Revision: Add links or references to general guidance; Comply with CDISC

AZACITIDINE

INTRAVENOUS, SUBCUTANEOUS

POWDER

050794

Editorial Revision:  Correct typos

BENZYL ALCOHOL

TOPICAL

LOTION

022129

Minor Revision: Add links or references to general guidance

BEXAROTENE

TOPICAL

GEL

021056

Minor Revision: Add links or references to general guidance

CICLESONIDE

INHALATION

AEROSOL, METERED

021658

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

CLINDAMYCIN PHOSPHATE

TOPICAL

 LOTION

050600

Editorial Revision:  Update the language (changing to common language)

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

CRISABOROLE

TOPICAL

OINTMENT

207695

Minor Revision: Add links or references to general guidance

DOCOSANOL

TOPICAL

CREAM

020941

Minor Revision: Add links or references to general guidance

FLUOROURACIL

TOPICAL

CREAM

016831

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

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

IPRATROPIUM BROMIDE

INHALATION

AEROSOL, METERED

021527

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

IRON SUCROSE

INTRAVENOUS

INJECTABLE

021135

Minor Revision:  Provide more details on product characterization

IVERMECTIN

TOPICAL

LOTION

202736

Minor Revision: Add links or references to general guidance

IVERMECTIN

TOPICAL

CREAM

206255

Minor Revision: Add links or references to general guidance

LEVONORGESTREL

INTRAUTERINE

INTRAUTERINE DEVICE

203159

Major Revision: Clarify in vitro BE study design; Add in vivo BE study; Add recommendations for device comparisons

LIDOCAINE

TOPICAL

OINTMENT

008048

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

LULICONAZOLE

TOPICAL

CREAM

204153

Minor Revision: Add links or references to general guidance

NITAZOXANIDE

ORAL

TABLET

021497

Minor Revision: Correction of fasted and fed state simulated intestinal fluid

OXYCODONE

ORAL

CAPSULE, EXTENDED RELEASE

208090

Major Revision: Add additional in vitro feeding tube studies

OZENOXACIN

TOPICAL

CREAM

208945

Minor Revision: Add links or references to general guidance

PENCICLOVIR

TOPICAL

CREAM

020629

Minor Revision: Add links or references to general guidance

PENTOSAN POLYSULFATE SODIUM

ORAL

CAPSULE

020193

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

PODOFILOX

TOPICAL

GEL

020529

Minor Revision:  Clarify in vivo study design

SILVER SULFADIAZINE

TOPICAL

CREAM

017381

Minor Revision: Add links or references to general guidance

SPINOSAD

TOPICAL

SUSPENSION

022408

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

SUCROFERRIC OXYHYDROXIDE

ORAL

CHEWABLE TABLET

205109

Minor Revision:  Add API sameness recommendation(s)

TACROLIMUS

TOPICAL

OINTMENT 0.03%

050777

Editorial Revision: Update the language (changing to common language)

Minor Revision: Add links or references to general guidance; Comply with Clinical Data Interchange Standards Consortium (CDISC)

TACROLIMUS

TOPICAL

OINTMENT 0.1%

050777

Editorial Revision: Update the language (changing to common language)

Minor Revision: Add links or references to general guidance;
Comply with CDISC

TESTOSTERONE

IMPLANTATION

PELLET

080911

Major Revision: Add additional partial AUC recommendation(s)

TRIAMCINOLONE ACETONIDE

INJECTION

INJECTABLE

012041; 014901

Editorial Revision: Correct typos

Minor Revision: Add information on newly approved strength(s) of the RLD

 

 

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