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ANDA Approval Process

The document outlines the Abbreviated New Drug Application (ANDA) process for the approval of generic drugs, emphasizing its reliance on bioequivalence studies rather than costly clinical trials. It details the regulatory framework, submission process, review timelines, and challenges faced in obtaining approval. The Waxman-Hatch Act is highlighted as a significant law that facilitates the ANDA process, ensuring the availability of affordable generic medications.

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Wasim Akram
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306 views13 pages

ANDA Approval Process

The document outlines the Abbreviated New Drug Application (ANDA) process for the approval of generic drugs, emphasizing its reliance on bioequivalence studies rather than costly clinical trials. It details the regulatory framework, submission process, review timelines, and challenges faced in obtaining approval. The Waxman-Hatch Act is highlighted as a significant law that facilitates the ANDA process, ensuring the availability of affordable generic medications.

Uploaded by

Wasim Akram
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd

Approval Processes and

Timelines Involved in ANDA


Introduction to ANDA
• ANDA (Abbreviated New Drug Application) is
submitted for the approval of generic drugs.
• It proves the generic drug is bioequivalent to
the brand-name drug.
• No need for costly clinical trials, making
generic drugs more affordable.
ANDA vs. NDA (New Drug
Application)
• NDA is required for a new drug's approval,
including safety & efficacy trials.
• ANDA is for generic drugs, requiring
bioequivalence proof.
• NDA requires extensive clinical data, while
ANDA relies on reference drug studies.
Regulatory Authorities for ANDA
Approval
• In the U.S., the FDA (Food and Drug
Administration) oversees ANDA approvals.
• The Office of Generic Drugs (OGD) within the
FDA reviews ANDA submissions.
• Ensures generic drugs meet the same quality
and efficacy as innovator drugs.
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
ANDA Submission Process
• 1. Pre-ANDA Activities
• 2. Bioequivalence Studies
• 3. ANDA Compilation
• 4. Filing and Review by FDA
• 5. Approval or Deficiency Response
Review and Approval Timelines
• Standard review timeline: 10 months
• Priority review: 8 months (for certain generics
addressing drug shortages)
•Additional delays may occur due to deficiencies
in submission.
Role of Bioequivalence Studies in
ANDA
• Bioequivalence (BE) ensures the generic drug
has the same absorption as the innovator.
• BE studies compare pharmacokinetic
parameters like Cmax and AUC.
• Conducted in healthy volunteers under fasting
& fed conditions.
Post-Approval Changes and
Amendments
• Minor changes: Annual reports
• Moderate changes: Prior approval
supplements
• Major changes: New ANDA submission is
required in some cases.
Challenges in ANDA Approval
• Patent and exclusivity issues
• FDA queries and deficiencies in submission
• Delays due to bioequivalence testing
• High competition in the generic drug market.
Case Study: ANDA Approval
Example
• Example: Generic drug approval for Metformin
ER.
• Bioequivalence study conducted against the
innovator drug.
• FDA approval granted within 10 months after
submission.
Waxman-Hatch Act
• The Waxman-Hatch Act, officially known as the Drug Price Competition and
Patent Term Restoration Act of 1984, is a U.S. federal law that established the
Abbreviated New Drug Application (ANDA) process for generic drugs

• Use of bioequivalence as a 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.
Conclusion
• ANDA approval is essential for ensuring
affordable generic drugs.
• The process involves bioequivalence studies
and regulatory review.
• Challenges exist, but the FDA aims to
streamline approvals.

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