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Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Drugs can be classified according to their chemical composition or their intended therapeutic application. For instance, anti-infective agents that possess the ability to eliminate pathogens or suppress their growth and reproduction can be grouped based on the organisms they target or their chemical structure. Furthermore, drugs can be divided into prescription, nonprescription, or controlled substances. Prescription medications, such as antibiotics, require oversight from a licensed healthcare...
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
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    The US FDA approved new drugs in early 2024 for primary care physicians. This update covers seven key medications, including sotatercept-csrk and resmetirom, aiding clinical practice.

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    Area of Science:

    • Pharmaceuticals and Therapeutics
    • Primary Care Medicine
    • Drug Approval Processes

    Background:

    • The US Food and Drug Administration (FDA) plays a crucial role in evaluating new medications.
    • Primary care settings require timely updates on newly approved drugs for effective patient management.
    • The journal's biannual Drug Update provides essential information for healthcare professionals.

    Purpose of the Study:

    • To review and highlight new drugs approved by the US FDA in the first half of 2024.
    • To provide primary care practitioners with concise information on relevant new medications.
    • To serve as a comprehensive resource for the winter 2025 Drug Update.

    Main Methods:

    • Review of US FDA drug approval data from January to June 2024.
    • Selection of drugs with significant relevance to primary care practice.
    • Compilation of key information for each highlighted medication.

    Main Results:

    • Seven new drugs were approved by the FDA in the first half of 2024.
    • The approved medications include sotatercept-csrk (Winrevair), aprocitentan (Tryvio), resmetirom (Rezdiffra), berdazimer (Zelsuvmi), ceftobiprole medocaril sodium (Zevtera), sofpironium (Sofdra), and ensifentrine (Ohtuvayre).
    • These drugs cover a range of therapeutic areas relevant to primary care.

    Conclusions:

    • Primary care physicians should be aware of these recent FDA-approved medications.
    • The introduction of these new drugs offers potential advancements in patient treatment.
    • This update facilitates informed prescribing decisions in primary care settings.