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This document provides a comprehensive chemistry review for the New Drug Application (NDA) of DIFICID™, evaluating its chemical composition, manufacturing processes, stability, and approval recommendations
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How to fill out Chemistry Review for NDA 201-699 DIFICID™
01
Obtain the Chemistry Review guidelines for NDA 201-699 DIFICID™.
02
Review the required sections outlined in the guidelines.
03
Gather all relevant data related to the chemistry of DIFICID™, including formulation, stability, and manufacturing process.
04
Fill in the required sections one by one, providing detailed and accurate information.
05
Ensure that all data is supported by appropriate references and studies.
06
Review the completed document for any inconsistencies or missing information.
07
Submit the Chemistry Review as per the submission guidelines provided.
Who needs Chemistry Review for NDA 201-699 DIFICID™?
01
Pharmaceutical companies developing products similar to DIFICID™.
02
Regulatory professionals responsible for submitting NDAs to the FDA.
03
Researchers and scientists involved in drug formulation and development.
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People Also Ask about
What class of BCS is Fidaxomicin?
Fidaxomicin is a BCS class 4 (low solubility & low permeability) compound. Low or no systemic availability is preferred because the infection/site of action is in the GI tract.
What class of antibiotics is fidaxomicin?
Fidaxomicin belongs to the class of medicines known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections. This medicine is available only with your doctor's prescription.
What class of BCS is aripiprazole?
( Conclusion: Based on its solubility, permeability and dissolution performance, aripiprazole can be classified as BCS Class IV drugs.
Is Dificid available in generic?
Dificid (fidaxomicin) is available as a tablet and suspension (liquid), but it isn't available as a lower-cost generic yet. Dificid (fidaxomicin) is taken by mouth twice per day. Side effects include nausea, vomiting, and stomach pain.
What group is fidaxomicin in?
Fidaxomicin is in a class of medications called macrolide antibiotics. It works by killing bacteria in the intestines. Fidaxomicin will not treat infections in any other part of the body.
What class of BCS is Iohexol?
Iohexol belongs to the BCS Class3 drug substance, based on its high solubility, namely one unit dose dissolves in a volume of less than one-tenth of 250 mL of water in the pH range tested (pH 1 to 7.5) as shown below.
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What is Chemistry Review for NDA 201-699 DIFICID™?
Chemistry Review for NDA 201-699 DIFICID™ is a comprehensive evaluation of the chemical composition, manufacturing processes, and quality control measures associated with the drug DIFICID™, which is used for the treatment of certain bacterial infections.
Who is required to file Chemistry Review for NDA 201-699 DIFICID™?
The sponsor of NDA 201-699 DIFICID™, typically the pharmaceutical company that developed the drug, is required to file the Chemistry Review.
How to fill out Chemistry Review for NDA 201-699 DIFICID™?
To fill out the Chemistry Review, the sponsor must provide detailed information about the drug's chemical properties, manufacturing procedures, analytical methods, and stability testing results, ensuring compliance with regulatory guidelines.
What is the purpose of Chemistry Review for NDA 201-699 DIFICID™?
The purpose of the Chemistry Review is to ensure that the drug DIFICID™ is chemically safe, effective, and manufactured consistently to meet the required quality standards for approval.
What information must be reported on Chemistry Review for NDA 201-699 DIFICID™?
The Chemistry Review must report information such as the active ingredients, formulation details, manufacturing process, in-process controls, analytical methods used for testing, stability data, and any relevant quality assurance measures.
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