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Accessdata fda drugsatfdadocs nda204026Orig1s000 - Food and Drug Administration

Accessdata fda drugsatfdadocs nda204026Orig1s000 - Food and Drug Administration 2025

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The document is an Exclusivity Summary for the New Drug Application (NDA) 204026 for Pomalidomide, a drug developed by Celgene Corporation. It outlines the administrative details, including the need for exclusivity determination, clinical data review requirements, and pediatric considerations. The summary discusses the approval process, exclusivity requests, and various regulatory questions related to clinical investigations and safety assessments. It emphasizes the importance of demonstrating efficacy and safety in patients with relapsed and refractory multiple myeloma who have undergone prior therapies.

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What is the FDA NDA?

New Drug Application (NDA) is a type of application in which a pharmaceutical manufacturer or its agent requests permission from the U.S. Food and Drug Administration (FDA) for a license to market a drug for one or more specified indications.

What are the four classifications of NDA?

NDA Classification Codes Type 1: New Molecular Entity (NME). An active ingredient that contains no active moiety that has been previously approved by the FDA. Type 2: New Active Ingredient. Type 3: New Dosage Form. Type 4: New Combination. Type 5: New Formulation or Other Differences.

What is the FDA NDA code?

The NDA classification code provides a way of categorizing new drug applications. The code evolved from both a management and a regulatory need to identify and group product applications based on certain characteristics, including their relationships to products already approved or marketed in the United States.

What is a NDA code?

Non-disclosure agreements (NDAs) are legally binding agreements to keep information confidential. They go by other names in certain contexts, including confidentiality agreements (CAs), confidential disclosure agreements (CDAs), and proprietary information agreements (PIAs).

How can I find out if a drug is FDA approved?

The Electronic Orange Book (EOB) Query enables searching of the approved drug list by active ingredient, proprietary name, applicant holder, applicant number or patent. The Approved Drug Products EOB Query web files are downloadable.

Where can I find the summary basis of approval?

SBAs are available through the FDAs Freedom of Information Office, 301-443-6310, and from the National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161.

What drug did the FDA just approve?

Today, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults.

What is an FDA NDC code?

Drugs are identified and reported using a unique, three-segment number called the National Drug Code (NDC) which serves as the FDAs identifier for drugs. FDA publishes the listed NDC numbers in the NDC Directory which is updated daily.

Accessdata fda drugsatfdadocs nda204026Orig1s000 - Food and Drug Administration 2025

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