ANDA

Question 1

What did the Hatch-Waxman Amendment establish?
What did it create a staute on?

Drug Price Competition and Patent Term Restoration Act

Answer 1

1. ANDA & bioequivalence as basis for approving generics
2. Created a statutory generic drug approval process

Question 2

What established the ANDA? What is an ANDA?

Answer 2

1. Hatch-Waxman Amendment
2. applications to market generics without repeating costly and
   duplicative clinical trials to establish safety and efficacy

Question 3

Which amendment allows for greater generic competition? Which one enganced protection for innovators?

Answer 3

Hatch-Waxman Amendment

Question 4

What did the Hatch-Waxman Amendment provide exclusivities to? For how long?

Answer 4

certain non-patent exclusivities, including Orphan drug exclusivity (7 years)

Question 5

What does the ANDA rely on?

Answer 5

safety and effectiveness
findings for listed drug product.

Question 6

In what book does the FDA publish patient info on approved drug products, including generics

Answer 6

orange

Question 7

In what book does the FDA publish patient info on veterinary drug products

Answer 7

green

Question 8

1. What must Generic drug companies establish regarding their generic drug?
2. What must they specifically show?

Answer 8

1. effective a duplicate
2. show it has same active ingredient, route of administration, dosage form,
   strength and intended use

5 - ARDSU