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FDA Approved Drugs: Changes to Approved Drugs01:26

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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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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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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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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 Approval Update.

Mary Choy

    P & T : a Peer-Reviewed Journal for Formulary Management
    |September 6, 2019
    PubMed
    Summary
    This summary is machine-generated.

    Three novel therapies show promise for challenging diseases. Alpelisib targets PIK3CA-mutated breast cancer, polatuzumab vedotin treats diffuse large B-cell lymphoma, and eculizumab is indicated for neuromyelitis optica spectrum disorder.

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    Area of Science:

    • Oncology
    • Immunology
    • Pharmacology

    Background:

    • Advances in targeted therapies and immunotherapies are transforming treatment paradigms for various cancers and autoimmune disorders.
    • Specific genetic mutations and disease pathways present opportunities for precision medicine approaches.
    • Neuromyelitis Optica Spectrum Disorder (NMOSD) is a rare autoimmune condition affecting the central nervous system.

    Purpose of the Study:

    • To review the efficacy and safety of alpelisib (Piqray) in patients with HR-positive/HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer.
    • To evaluate the use of polatuzumab vedotin-piiq (Polivy) in the treatment of diffuse large B-cell lymphoma (DLBCL).
    • To discuss the role of eculizumab (Soliris) in managing neuromyelitis optica spectrum disorder (NMOSD).

    Main Methods:

    • Clinical trial data analysis for alpelisib in advanced breast cancer.
    • Review of studies investigating polatuzumab vedotin in DLBCL treatment regimens.
    • Examination of clinical evidence supporting eculizumab's efficacy in NMOSD.

    Main Results:

    • Alpelisib demonstrated significant improvements in progression-free survival for patients with PIK3CA-mutated breast cancer.
    • Polatuzumab vedotin showed efficacy as part of combination therapy for relapsed or refractory DLBCL.
    • Eculizumab proved effective in reducing relapse rates and preventing disability progression in NMOSD patients.

    Conclusions:

    • Alpelisib offers a targeted treatment option for a specific subset of advanced breast cancer patients.
    • Polatuzumab vedotin represents a valuable addition to the therapeutic landscape for diffuse large B-cell lymphoma.
    • Eculizumab provides a crucial therapeutic advance for individuals with neuromyelitis optica spectrum disorder.