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202192Orig1s000 - gov fda accessdata www - Food and Drug - accessdata fda

202192Orig1s000 - gov fda accessdata www - Food and Drug - accessdata fda 2025

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The document outlines the regulatory review process for the New Drug Application (NDA) 202192 for Jakafi (ruxolitinib) tablets, intended for treating myelofibrosis. It includes details on post-marketing requirements (PMRs) and commitments (PMCs) related to safety findings, study protocols, and milestones for ongoing clinical trials. The document emphasizes the need for long-term data on drug discontinuation effects and myelosuppression, as well as efficacy outcomes over three years. Additionally, it discusses labeling reviews, clinical inspections of trial sites, and pharmacological assessments to ensure compliance with safety standards.

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What class of BCS is ruxolitinib Hemifumarate?

It is highly soluble in water, most soluble at low pH (pH 3.3) at 37oC. The pKa is 4.3 and 11.8. The BCS is Class 1. Jakavi tablets contain 5 mg, 15 mg and 20 mg of ruxolitinib as the phosphate salt.

Where can I find information about a product that is not approved by the FDA?

Drugs marketed in the U.S., with or without FDA approval, can be identified in the following databases: National Drug Code (NDC) Directory publishes data derived from information submitted to the agency as part of drug listing requirements, including information on unapproved drugs.

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

Drugs@FDA lists most prescription and over-the-counter (OTC) drug products approved since 1939. Drugs@FDA helps consumers find generic equivalents and other possible appropriate alternatives to their approved products as well as the products drug label. FDA updates this list every day.

How to search if a drug is FDA approved?

Look up the drug or biological product in Drugs @ FDA. Most FDA-approved human drugs and therapeutic biological products are listed in Drugs @ FDA, a searchable database. The database allows you to search by drug name, active ingredient, or application (NDA, ANDA, or BLA) number.

How will you find an approved drug product by the USFDA?

The Electronic Orange Book (EOB) Query enables searching of the approved drug list by active ingredient, proprietary name, applicant holder, applicant number or patent.

How to check if a company is FDA approved?

0:28 1:45 And device listing. Section this is where the magic. Happens. But remember youre not looking for aMoreAnd device listing. Section this is where the magic. Happens. But remember youre not looking for a rabbit in a hat youre looking for a company in a list. Once youre there youll see a search box.

What are the pharmacokinetics of ruxolitinib?

Ruxolitinib pharmacokinetics can be described with a two-compartment model and linear elimination. Volume of distribution differs between men and women, likely related to bodyweight differences. Metabolism is mainly hepatic via CYP3A4 and can be altered by CYP3A4 inducers and inhibitors.

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What class of BCS is ruxolitinib Hemifumarate?

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How will you find an approved drug product by the USFDA?

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