An abbreviated new drug application is submitted to the FDA Office of Generic Drugs. let us learn about generic drug products before the ANDA application Process.

A Generic drug product is comparable to the innovator in terms of strength, dosage form, route of administration, performance, and intended use. But the main point of difference is generics are available at affordable prices than the innovator products. ANDA application is submitted when patent or market exclusivity of innovator products comes near to end. Generic manufacturers apply to the FDA, CDER -office of generic drugs.

ANDA applications do not contain pre-clinical and clinical data and they are based on bioequivalence, this is why generic applicants must prove their product is bioequivalent to the innovator. The use of the bioequivalence concept for generic drug approval is due to the Hatch-Waxman Act.

A generic drug approval is given by reviewing the following

1. Bioequivalence data
2. Chemistry and microbiology data
3. Request based plant inspection
4. Labelling Review

Let us see the overview of ANDA application process

Application: Form FDA 356h: Application to Market a New or Abbreviated New Drug or Biologic for Human Use. This application is available at the FDA website.

Step -1 Applicant file an ANDA

Step-2 if the application is acceptable and complete ( if not refuse to file letter issued )

Step-3 Then review for following is done – Bioequivalence review, chemistry and microbiology review, request for plant inspection and labelling review

Step-4 If the above review is acceptable then pre- approval inspection acceptance ( if review is not acceptable then Bioequivalence deficiency letter issued )

Step-5 After inspection, based on results ANDA is approved .