Different between NDA and ANDA

 

Different between NDA & ANDA

NDA

ANDA

New drug application

Abbreviated new drug application

Critical component for drug approval process which required to submit to USFDA before drug commercialization.

ANDA contains data which is submitted to FDA for the review and potential approval of a generic drug product.

The NDA provide enough information to permit FDA reviewer to reach safety, efficacy and quality for pharmaceutical production.

Once approved an applicant many manufacturing and market the generic drug product to provide a safe, effective, lower cost alternative to the brand- name drug it references.

Applicable for new drug

Applicable for generic drug

Take longer time (12-15 years)

Compare to NDA less time taken (1-2 years)

More expense of money

Comparatively less

Cost of drugs are more

Cost of drugs are less

Nonclinical studies and clinical investigations are essential

Nonclinical studies and clinical investigations are nonessential except BA & BE.

 

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