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Regulation of Generic
Animal Drugs in the
United States
VICH Outreach Forum
June 25, 2014
Brussels, Belgium
What is a Generic New
Animal Drug?
• Copy of an FDA-approved brand-name
reference listed new animal drug (RLNAD)
• Same as brand name drug in dosage form,
strength, route of administration, quality,
performance characteristics, and intended
use
• Must demonstrate bioequivalence to the
RLNAD or qualify for a waiver of this
requirement (biowaiver)
• Manufacturing, packaging, and testing sites
must pass the same quality standards as
those of brand name drugs
What is the Law that
provides for Generic Animal
Drugs?
• Generic Animal Drug and Patent
Term Restoration Act (GADPTRA)
– Amended the Federal Food Drug and
Cosmetic Act in 1988.
– Approval of generic new animal drugs
– Patent term restoration
GADPTRA
• Requirements for approval of a
generic animal drug
– Same active ingredient,
concentration (strength), dosage
form, and route of administration
– Bioequivalent to the approved
pioneer drug product
– Sameness in labeling
GADPTRA
• Patent term restoration
– Provision allowing for additional years
to be added to the RLNAD patent
based on the time required for drug
approval
– Exclusivity periods
• 3-year Marketing exclusivity for addition of
new species or claim to an approved drug
label
• 5-year Marketing exclusivity for new drug
entity never approved before
What differences can a
generic drug have from the
RLNAD?
• Suitability Petition
– Provision for requesting a change in active
ingredient (combination products), route of
administration, dosage form, and/or strength
from that of an approved reference listed new
animal drug
– Petition is approved unless new safety and
effectiveness studies are required for
requested change(s)
– Labeling changes are permitted consistent
with the change granted.
• e.g., change in dosage form may require different
instructions for use or administration
What is the Regulatory
Process for Generic
Animal Drugs?
• Generic Investigational New Animal Drug
(JINAD) File
– Identify the RLNAD
– Request biowaiver for selected drug products
– Option to do phased review of each technical
section: Environmental, Patent and Marketing
Exclusivity, Bioequivalence, Chemistry, and
Labeling
– When completed – submit an administrative
application.
What is the Regulatory
Process for Generic
Animal Drugs?
• Abbreviated New Animal Drug Application
(ANADA)
– File containing all the technical sections for
approval
– New target animal safety and effectiveness
trials or Human Food Safety information (other
than tissue residue data for drugs used in food
producing animals) are not required
• Tissue residue data are not required for drug
products that are granted a biowaiver
What innovations can be
made to a generic animal
drug?
• Sponsor may also request a change
requiring new safety and effectiveness
studies to support the request.
– i.e., new claim, species, or indication
• Approval process
– B1 supplement: Two step process – get
approval of an ANADA then submit a
supplement with new data.
– The new claim may qualify for a 3-year
marketing exclusivity
Animal Generic Drug User
Fee Act (AGDUFA)
• August 14, 2008, signed into law by
President Bush
• This Act amends the Food, Drug and
Cosmetic Act
– Authorizing the first ever generic animal drug
user fee program
– A first for either human or animal generic
drugs
• The program provides consumers with
multiple sources of animal drugs, better
ensuring an adequate supply of animal
drugs
AGDUFA
• The program provides consumers
with multiple sources of animal
drugs, better ensuring an adequate
supply of animal drugs
• The performance of the generic new
animal drug review process is
enhanced
• Allows FDA to better ensure that
generic new animal drug products
are safe and effective
Questions?