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Product-Specific Guidances for Generic Drug Development

To successfully develop and manufacture a generic drug product, an applicant should consider that their product is expected to be: pharmaceutically equivalent to its reference listed drug (RLD), i.e., to have the same active ingredient, dosage form, strength, and route of administration under the same conditions of use; bioequivalent to the RLD, i.e., to show no significant difference in the rate and extent of absorption of the active pharmaceutical ingredient; and, consequently, therapeutically equivalent, i.e., to be substitutable for the RLD with the expectation that the generic product will have the same safety and efficacy as its RLD.

According to 21 CFR 320.24, different types of evidence may be used to establish bioequivalence (BE) for pharmaceutically equivalent drug products, including in vivo or in vitro testing, or both. The selection of the method used to demonstrate BE depends upon the purpose of the study, the analytical methods available, and the nature of the drug product. Under this regulation, applicants must conduct BE testing using the most accurate, sensitive, and reproducible approach available among those set forth in 21 CFR 320.24. As the initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).

To facilitate generic drug product availability and further assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, the FDA publishes product-specific guidances (PSG). PSGs describe the Agency's current thinking and expectations to develop generic drug products therapeutically equivalent to specific RLDs.

The FDA publishes PSGs to foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs.

PSGs are published in an incremental manner and listed below in alphabetical order according to the active ingredient's name. The most recently published guidances (new and revised) are listed below.

The implementation of FDA's commitments under the Generic Drug User Fee Amendments Reauthorization of 20221 (GDUFA III). with regard to issuance of PSGs is effective on October 1, 2022. Under GDUFA III, the FDA will issue PSGs consistent with the following goals:

  • For complex products1,2 approved in new drug applications (NDAs) on or after October 1, 2022, a PSG will be issued for 50 percent of such NDA products within two years after the date of approval, and for 75 percent of such NDA products within three years after the date of approval.
  • FDA will continue to develop PSGs for complex products approved prior to October 1, 2022, for which no PSG has been published.
  • For non-complex drug products approved in NDAs on or after October 1, 2022, that contain a new chemical entity (NCE) (as described in section 505(j)(5)(F)(ii) of the FD&C Act), a PSG will be issued within two years after the date of approval for 90 percent of such products.
In addition to GDUFA III PSG goals, the FDA considers several factors when prioritizing PSG development. The FDA evaluates the generic industries and other stakeholders' interest in products that do not have a PSG through controlled correspondences, public requests, and pre-ANDA meeting requests.

The FDA also evaluates drug availability and accessibility and considers public health priorities, including but not limited to, public health emergencies and drug safety and efficacy updates. In addition to these elements, the FDA continually assesses the status and outcomes of ongoing GDUFA research to ensure there are sufficient and adequate data and evidence to support the development of PSGs that align with the FDA's current scientific thinking.

Sponsors and investigators of any investigational new drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or BE and/or bioavailability (BA) studies involving human subjects in support of an ANDA should refer to the current RLD labeling, including BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections. This information should be considered during study design and conduct, including attention to appropriate subject screening and selection, inclusion and exclusion criteria, and appropriate clinical safety monitoring.

In addition to the provided information, sponsors and investigators of any Investigational New Drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or BE and/or bioavailability (BA) studies involving human subjects in support of an ANDA should refer to the current RLD labeling, including BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections. This information should be considered during study design and conduct; including attention to appropriate subject screening and selection, inclusion and exclusion criteria, and appropriate clinical safety monitoring.

Some of the PSGs include discussion regarding data formats. Please note that under section 745A(a) of the Federal Food, Drug, and Cosmetic Act, separate Agency-wide guidances specify the electronic formats, subject matter, and scope of applicability for certain submissions, including submissions to ANDAs. As these are finalized guidances and subject to described timetables for implementation, these guidances are binding and the electronic format(s) specified must be used for submissions to ANDAs. Questions and general information regarding the preparation of submissions in electronic format may be directed to CDER at esub@fda.hhs.gov. Questions regarding submission of datasets to CDER may be sent to edata@fda.hhs.gov.

COMMENTS: The Agency is seeking feedback and considers comments to the docket on these guidances. You may submit comments on any guidance at any time as follows: Submit electronic comments to Docket FDA-2007-D-0369. For further information on submitting electronic comments, refer to (www.regulations.gov). You may also mail your written comments to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All submissions received must include the Docket No. [FDA-2007-D-0369]. Please contact the Regulations.gov Help Desk at 1-877-378-5457 (toll free) or at (www.regulations.gov/support) for assistance regarding submissions.

The FDA posts plans for issuing new or revised PSGs on the Upcoming Product-Specific Guidances for Generic Drug Product Development web page

For additional information on development of generic drug products, please refer to FDA's guidance document database.

1GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III Commitment Letter)

2Classifying Approved New Drug Products and Drug-device combination Products as Complex Products for Generic Drug Development Purposes (CDER MAPP 5240.10)

Total number of currently published PSGs: 2223

Product-Specific Guidances for Specific Products Arranged by Active Ingredient

Search by Active Ingredient or by RLD or RS Number

Newly Added Guidances since August 22, 2024

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Air Polymer-Type A https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212279.pdf Draft Intrauterine Foam 212279 08/22/2024
Fezolinetant https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216578.pdf Draft Oral Tablet 216578 08/22/2024
Heparin Sodium; Taurolidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214520.pdf Draft N/A Solution 214520 08/22/2024
Leniolisib Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217759.pdf Draft Oral Tablet 217759 08/22/2024
Naloxone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217722.pdf Draft Nasal Spray, Metered 217722 08/22/2024
Nedosiran Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215842.pdf Draft Injection Solution 215842 08/22/2024
Nirmatrelvir; Ritonavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217188.pdf Draft Oral Tablet; Tablet 217188 08/22/2024
Pegcetacoplan https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217171.pdf Draft Intravitreal Solution 217171 08/22/2024
Risperidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212849.pdf Draft Intramuscular For Suspension, Extended Release 212849 08/22/2024
Sotagliflozin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216203.pdf Draft Oral Tablet 216203 08/22/2024
Tafluprost https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202514.pdf Draft Ophthalmic Solution, Drops 202514 08/22/2024
Teriparatide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021318.pdf Draft Subcutaneous Solution 021318 08/22/2024
Tofersen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215887.pdf Draft Intrathecal Solution 215887 08/22/2024
Trofinetide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217026.pdf Draft Oral Solution 217026 08/22/2024

Newly Revised Guidances since August 22, 2024

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020503.pdf Draft Inhalation Aerosol, Metered 020503 020983 021457 08/22/2024
Albuterol Sulfate; Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021747.pdf Draft Inhalation Spray, Metered 021747 08/22/2024
Apalutamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210951.pdf Draft Oral Tablet 210951 08/22/2024
Azelaic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020428.pdf Draft Topical Cream 020428 08/22/2024
Bempedoic Acid; Ezetimibe https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211617.pdf Draft Oral Tablet 211617 08/22/2024
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021949.pdf Draft Inhalation Powder, Metered 021949 08/22/2024
Bupropion Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020358.pdf Draft Oral Tablet, Extended Release 020358 020711 08/22/2024
Carvedilol Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022012.pdf Draft Oral Capsule, Extended Release 022012 08/22/2024
Ciprofloxacin Hydrochloride; Hydrocortisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020805.pdf Draft Otic Suspension/Drops 020805 08/22/2024
Ciprofloxacin; Dexamethasone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021537.pdf Draft Otic Suspension/Drops 021537 08/22/2024
Cladribine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022561.pdf Draft Oral Tablet 022561 08/22/2024
Dalfampridine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022250.pdf Draft Oral Tablet, Extended Release 022250 08/22/2024
Dapagliflozin; Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205649.pdf Draft Oral Tablet, Extended Release 205649 08/22/2024
Donepezil Hydrochloride; Memantine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206439.pdf Draft Oral Capsule, Extended Release 206439 08/22/2024
Fentanyl Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022569.pdf Draft Nasal Spray, Metered 022569 08/22/2024
Ferric Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205874.pdf Draft Oral Tablet 205874 08/22/2024
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209482.pdf Draft Inhalation Powder 209482 08/22/2024
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021433.pdf Draft Inhalation Aerosol, Metered 021433 08/22/2024
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020833.pdf Draft Inhalation Powder 020833 08/22/2024
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208798.pdf Draft Inhalation Powder 208798 08/22/2024
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208799.pdf Draft Inhalation Powder 208799 08/22/2024
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021254.pdf Draft Inhalation Aerosol, Metered 021254 08/22/2024
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021077.pdf Draft Inhalation Powder 021077 08/22/2024
Halobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019968.pdf Draft Topical Ointment 019968 08/22/2024
Hydrochlorothiazide; Metoprolol Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021956.pdf Draft Oral Tablet, Extended Release 021956 08/22/2024
Hydromorphone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021217.pdf Draft Oral Tablet, Extended Release 021217 08/22/2024
Ibrutinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210563.pdf Draft Oral Tablet 210563 08/22/2024
Levalbuterol Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021730.pdf Draft Inhalation Aerosol, Metered 021730 08/22/2024
Levomilnacipran Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204168.pdf Draft Oral Capsule, Extended Release 204168 08/22/2024
Memantine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022525.pdf Draft Oral Capsule, Extended Release 022525 08/22/2024
Metformin Hydrochloride; Sitagliptin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202270.pdf Draft Oral Tablet, Extended Release 202270 08/22/2024
Metformin Hydrochloride;Saxagliptin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200678.pdf Draft Oral Tablet, Extended Release 200678 08/22/2024
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021067.pdf Draft Inhalation Powder 021067 08/22/2024
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019516.pdf Draft Oral Tablet, Extended Release 019516 08/22/2024
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021260.pdf Draft Oral Capsule, Extended Release 079040 08/22/2024
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020616.pdf Draft Oral Capsule, Extended Release 020616 08/22/2024
Naloxone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208411.pdf Draft Nasal Spray, Metered 208411 08/22/2024
Olodaterol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203108.pdf Draft Inhalation Spray, Metered 203108 08/22/2024
Olodaterol Hydrochloride; Tiotropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206756.pdf Draft Inhalation Spray, Metered 206756 08/22/2024
Oxcarbazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202810.pdf Draft Oral Tablet, Extended Release 202810 08/22/2024
Oxymorphone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021610.pdf Draft Oral Tablet, Extended Release 021610 08/22/2024
Phentermine Hydrochloride;Topiramate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022580.pdf Draft Oral Capsule, Extended Release 022580 08/22/2024
Posaconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205053.pdf Draft Oral Tablet, Delayed Release 205053 08/22/2024
Pramipexole Dihydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022421.pdf Draft Oral Tablet, Extended Release 022421 08/22/2024
Progesterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022057.pdf Draft Vaginal Insert 022057 08/22/2024
Promethazine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_010926.pdf Draft Rectal Suppository 010926 08/22/2024
Quetiapine Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022047.pdf Draft Oral Tablet, Extended Release 022047 08/22/2024
Tacrolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206406.pdf Draft Oral Tablet, Extended Release 206406 08/22/2024
Tapentadol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200533.pdf Draft Oral Tablet, Extended Release 200533 08/22/2024
Tiotropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021936.pdf Draft Inhalation Spray, Metered 021936 08/22/2024
Tramadol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021692.pdf Draft Oral Tablet, Extended Release 021692 08/22/2024
Trospium Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022103.pdf Draft Oral Capsule, Extended Release 022103 08/22/2024
Venlafaxine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022104.pdf Draft Oral Tablet, Extended Release 022104 08/22/2024
Verteporfin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021119.pdf Draft Injection Injectable 021119 08/22/2024
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