February 23, 2024

Abbreviated New Drug Application (ANDA) Unit II Regulatory Approval Process

Abbreviated New Drug Application ANDA : Unit II Regulatory Approval Process


It’s an application made for approval of Generic Drugs. The sponsor is not required to reproduce the clinical studies that were done for the original, brand name product. Instead, generic drug manufacturers must demonstrate that their product is the same as, and bioequivalent to, a previously approved brand name product. Generic drug applications are referred to Abbreviated New Drug Application.

Pharmaceutical companies must admit ANDAs and receive FDA’s approval before marketing new generic drugs according to 21CFR 314.105(d).

Once ANDA is approved, an applicant can manufacture and market generic drug to provide safe, effective and low-cost alternative of innovator drug product to the public.

Generic drugs are termed ‘abbreviated’ as they are not required to include preclinical and clinical data to establish safety and efficacy. They must scientifically demonstrate bioequivalence to innovator (brand name) drug.

A generic drug is comparable to Innovator drug I dosage form, strength, route of administration, quality, performance and Intended use. One of the ways to demonstrate bioequivalence is to measure the time taken by generic drug to reach bloodstream in 24-36 healthy volunteers.

The time and amount of active ingredients in the bloodstream should be comparable to those of innovator drug. Use of bioequivalence as base for approving generic drug products was established in 1984, also known as Waxman-Hatch Act. It is because of this act that generic drugs are cheaper without conducting costly and duplicative clinical trials.

Code of Federal Regulations

The following regulations apply to ANDA process:

  • 21 CFR 314 : Applications for FDA approval to market a New Drug or Antibiotic Drug.
  • 21 CFR 320: Bioavailability and Bioequivalence requirements.
  • 21 CFR 310: New Drugs.

Office of Generic Drug (OGD) strongly encourages submission of bioequivalence, chemistry and labeling portions of the application in electronic format.

Format and Content of ANDA

Copies of the Abbreviated application are required to be submitted;

  • an archival copy,
  • a review copy and
  • a field copy.

An Archival copy shall contain the following: Application form, Table of Contents, Basis for ANDA submission, Conditions of use, Active Ingredients, Route of Administration, Dosage form and Strength, Bioequivalence and Bioavailability, Labeling, Chemistry, Manufacturing and Controls, Samples, Patent Certification, Financial Certification or disclosure statement.

Other Information: Under Section 314.94 (a) (12), the patent certification includes one of the following:

(a) Paragraph I Certification: That the patent information has not been submitted to the FDA.

(b) Paragraph II Certification: That the patent has expired.

(c) Paragraph III Certification: That the patent will expire (on the date of marketing).

(d) Paragraph IV Certification: That the patent is invalid, unenforceable, or will not be infringed by the manufacture, use or sale of generic drug.

Difference between Submission of NDA and ANDA

NDA requires the submission of

  • Well-controlled clinical studies to demonstrate effectiveness.
  • Preclinical and clinical data to show safety.
  • Details of Manufacturing and Packaging.
  • Proposed annotated Labeling.

In contrast, ANDA requires the submission of

  • A detailed description of components.
  • Manufacturing, Controls, Packaging, data to assure bioequivalence and bioavailability and Labeling.

Final Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise

Final Year B Pharm Sem VIIBP701T Instrumental Methods of Analysis Theory
BP702T Industrial Pharmacy TheoryBP703T Pharmacy Practice Theory
BP704T Novel Drug Delivery System TheoryBP705 P Instrumental Methods of Analysis Practical
Final Year B Pharm Sem VIIBP801T Biostatistics and Research Methodology Theory
BP802T Social and Preventive Pharmacy TheoryBP803ET Pharmaceutical Marketing Theory
BP804ET Pharmaceutical Regulatory Science TheoryBP805ET Pharmacovigilance Theory
BP806ET Quality Control and Standardization of Herbals TheoryBP807ET Computer-Aided Drug Design Theory
BP808ET Cell and Molecular Biology TheoryBP809ET Cosmetic Science Theory
BP810ET Experimental Pharmacology TheoryBP811ET Advanced Instrumentation Techniques Theory
BP812ET Dietary supplements and NutraceuticalsPharmaceutical Product Development

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