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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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Drug interactions occur when the pharmacological effect of one drug is altered by another substance, either enhancing or diminishing its activity. The drug whose activity is altered is known as the object drug, and the substance causing the alteration is called the agent drug or the precipitant. The net effects of these interactions are mostly undesirable, leading to decreased effectiveness or increased adverse effects. In rare cases, interactions can be beneficial, such as the enhanced...
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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
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Factors Influencing Drug Absorption: Drug Dissolution01:27

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The pharmacokinetic journey of drugs from solid oral dosage forms into systemic circulation is multifaceted. It begins with disintegration, a prerequisite ensuring a solid dosage form's subdivision into minute particles. Dissolution occurs next as these granulated entities solubilize in gastrointestinal fluids. This solubilization is crucial for the succeeding stage, permeation, which describes the traversal of the drug across the intestinal membrane and its subsequent entry into the blood...
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Drug binding to proteins is a complex phenomenon influenced by various drug-related factors, each playing a significant role in the interaction between drugs and proteins within the body.
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A drug interaction occurs when the concurrent use of another drug, food, or an external substance alters the pharmacological activity of a drug. This interaction can modify the action of the original drug, affecting its effectiveness and safety.Drug–food interactions are significant as they impact drug absorption, metabolism, and excretion. For example, grapefruit juice is a well-known disruptor of drug metabolism. It inhibits the cytochrome P450 3A4 enzyme, crucial for the metabolism of...
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The Drug Update: Recent drug approvals, winter 2026 edition.

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    Area of Science:

    • Pharmacology
    • Immunology
    • Gastroenterology

    Background:

    • The US FDA continuously approves new therapeutic agents.
    • Primary care practices require timely updates on novel medications and vaccinations.
    • Emerging treatments address unmet needs in various medical fields.

    Purpose of the Study:

    • To summarize key US FDA drug and vaccine approvals from the first half of 2025.
    • To highlight medications relevant for primary care practitioners.
    • To inform clinicians about new treatment options and indications.

    Main Methods:

    • Review of US FDA approval data for the first half of 2025.
    • Identification of drugs and vaccines with primary care relevance.
    • Categorization of new indications for existing therapies.

    Main Results:

    • Approval of suzetrigine (Journavx) and gepotidacin (Blujepa).
    • Introduction of meningococcal groups A, B, C, W, and Y vaccine (Penmenvy).
    • New approvals include clesrovimab-cfor (Enflonsia), acoltremon (Tryptyr), and a new indication for guselkumab (Tremfya) in Crohn's disease.

    Conclusions:

    • Several significant pharmaceutical and biological products were approved by the FDA in early 2025.
    • These approvals offer new therapeutic options for primary care and specialized fields.
    • Clinicians should be aware of these advancements for patient care.