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  4. CVM GFI #279 Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting
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GUIDANCE DOCUMENT

CVM GFI #279 Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting June 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-1275

Docket Number:
FDA-2023-D-1275
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance describes an approach to satisfy the requirements for the completion of the Bioequivalence technical section for generic Type A medicated articles (TAMAs) containing poorly soluble, locally acting, active pharmaceutical ingredients (APIs) that have little to no systemic absorption, and for which blood level studies are not considered appropriate to demonstrate product bioequivalence.  The suggested approach described in this guidance uses a combination of in vitro and in vivo data to support a determination of bioequivalence to address the unique challenges associated with demonstrating bioequivalence of TAMAs containing poorly soluble, locally acting APIs that have little to no systemic absorption.

Questions?

Contact Point
Ian S. Hendricks
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-172
Rockville, MD 20855
Ian.Hendricks@fda.hhs.gov
240-402-0853
Marilyn Martinez
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-100
Rockville, MD 20855
Marilyn.Martinez@fda.hhs.gov
240-402-0635
Catherine Finnegan
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-140
Rockville, MD 20855
Catherine.Finnegan@fda.hhs.gov
240-402-0650
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