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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 22-554

CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 22-554 2025

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The document is an administrative correspondence from the Center for Drug Evaluation and Research regarding application number 22-554 for Xifaxan (Rifaximin) tablets, submitted by Salix Pharmaceuticals, Inc. It outlines the pediatric considerations for the drug's indications, including its approved use for treating Travelers' Diarrhea and reducing the risk of hepatic encephalopathy in patients with liver disease. The document discusses pediatric study requirements, waivers, deferrals, and labeling considerations related to pediatric populations.

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What is the FDA application number?

Application Number Definition. What exactly is a pre-assigned application number? A pre-assigned application number is a unique six-digit number, e.g., 012345, assigned to sponsors to enable them to identify their application. The FDA requires that you use this number any time you submit an eCTD application.

What does the Center for Drug Evaluation and Research do?

The Center makes sure that safe and effective drugs are available to improve the health of consumers. CDER ensures that prescription and over-the-counter drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks.

How do I find my drug identification number?

You can also find the DIN on your prescription bottle or box, depending on the type of packaging your medication comes in. The DIN is typically located on the sticker label of the packaging. If you dont have a pharmacy receipt, you can upload a photo of your prescription bottle or box and add it to your claim.

What is the drug application number?

What is the abbreviated new drug application (ANDA) number? The abbreviated new drug application (ANDA) number is a six-digit number assigned by FDA staff to each ANDA. An ANDA is an application containing data for the review and ultimate approval of a generic drug product by the Food Drug Administration.

What is the pharmacology of rifaximin?

Rifaximin is a semisynthetic, rifamycin-based non-systemic antibiotic, meaning that the drug will not pass the gastrointestinal wall into the circulation as is common for other types of orally administered antibiotics. It has multiple indications and is used in treatment of travellers diarrhea caused by E.

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How to obtain an IND number?

FDA Form 1571 completed with the treating physician listed as the sponsor. If the request is approved, an IND number will be issued by the FDA. The IND is considered active (i.e. treatment may proceed) 30 days after the FDA receives the IND submission or upon earlier notification of the physician by the FDA.

What is the central for drug evaluation and research?

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.

What is a drug code number?

The NDC, or National Drug Code, is a unique 10-digit, 3-segment number. It is a universal product identifier for human drugs in the United States.

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