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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

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Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
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Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

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Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

177
Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Pharmaceutical Approval Update.

Michele B Kaufman

    P & T : a Peer-Reviewed Journal for Formulary Management
    |September 7, 2018
    PubMed
    Summary
    This summary is machine-generated.

    New drug approvals include baricitinib for rheumatoid arthritis, plazomicin for complicated urinary tract infections, and cannabidiol for specific seizure disorders. These medications offer new treatment options for various conditions.

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    Area of Science:

    • Pharmacology and Therapeutics
    • Drug Development
    • Medical Innovation

    Background:

    • Rheumatoid arthritis, complicated urinary tract infections, and specific epilepsy syndromes represent significant unmet medical needs.
    • Existing treatments for these conditions may have limitations in efficacy or tolerability.
    • The development of novel therapeutic agents is crucial for improving patient outcomes.

    Purpose of the Study:

    • To review recent drug approvals and their indications.
    • To highlight new pharmacological interventions for rheumatoid arthritis, complicated urinary tract infections, and rare seizure disorders.
    • To inform healthcare professionals about emerging treatment options.

    Main Methods:

    • Review of regulatory agency approvals for new medications.
    • Analysis of clinical trial data supporting efficacy and safety.
    • Summary of approved indications and target patient populations.

    Main Results:

    • Baricitinib (Olumiant) tablets approved for rheumatoid arthritis.
    • Plazomicin (Zemdri) injection approved for complicated urinary tract infections.
    • Cannabidiol (Epidiolex) oral solution approved for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.

    Conclusions:

    • The approval of these drugs signifies advancements in treating rheumatoid arthritis, complex UTIs, and specific pediatric epilepsy syndromes.
    • These new therapies offer valuable alternatives for patients who have not responded adequately to existing treatments.
    • Continued research and development are essential for addressing diverse therapeutic challenges.