AND and ANDA

What is AND and ANDA?

The term "Abbreviated New Drug" refers to a generic version of a previously
approved brand-name drug. An Abbreviated New Drug Application (ANDA) is the
regulatory submission made to seek approval for marketing and selling a generic
version of a drug. The term "Abbreviated" reflects the streamlined nature of the
application process, where the generic manufacturer demonstrates that their
product is bioequivalent to the original, often relying on the safety and efficacy data
of the reference (brand-name) drug already approved by the regulatory authorities.
Basic generic drug requirements

● Same active ingredient(s)

● Same route of administration
● Same dosage form
● Same strength
● Same conditions of use
● Inactive ingredients already approved in a similar NDA
○
Goals of ANDA

● To reduce the price of the drug.

● To reduce the time development
● Increase the bioavailability of the drug in comparison to references list
drug.
Generic drug approval
● Generic drug approval involves the submission of an Abbreviated New Drug
Application (ANDA) to regulatory authorities, such as the U.S. Food and Drug
Administration (FDA).
● The generic drug manufacturer provides evidence that their product is
bioequivalent to the reference drug, demonstrating similar safety, efficacy, and
quality. This often includes data on the drug's formulation, manufacturing
process, and labeling.
●
● If the regulatory agency determines that the generic drug meets the required
standards, it is granted approval.
Indispensability Ground For Generics

● Contain the same active ingredients as the innovator drug (inactive

ingredients may
● vary).
● Must be identical in strength, dosage form, and route of administration.
● Must have same use/indications.
● Must be bioequivalent.
● Must have same batch requirements for Identity, Safety & Purity.
● Must follow strict standards of FDA's GMPs.
ANDA
Review
process
Information required for filling ANDA
● Product’s formulation
● Manufacturer’s procedure
● Control procedure
● Testing,
● Facilities
● Dissolution profile
● Labeling
Thank you🦋