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Mar 25, 2024 · Non-Proprietary Name. The non-proprietary name of a drug is the name accepted by a competent scientific body or authority, such as the USAN or BAN. The non-proprietary names of newer drugs are kept uniform by an agreement to use the Recommended International Nonproprietary Name (rINN) in all member countries of the World Health Organization (WHO).
Jan 18, 2017 · On January 12, 2017, the U.S. Food and Drug Administration (“FDA”) released a final Guidance for Industry, Nonproprietary Naming of Biological Products, as part of the Agency’s ongoing efforts to implement the Biologics Price Competition and Innovation Act (BPCIA) of 2009.
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respects in which the drug differs. See FDCA 501(b) and 502(e)(3)(b), and the Food and Drug Administration (FDA) regulations at 21 CFR 299.5. The FDCA requires all drugs to have an “established name,” which is a nonproprietary name, other than the applicable systematic chemical name. The established name is almost always tied to the drug ...
A drug is defined by U.S. law as any substance (other than a food or device) intended for use in the diagnosis, cure, relief, treatment, or prevention of disease or intended to affect the structure or function of the body. (Oral contraceptives are an example of drugs that affect the function of the body rather than a disease.)
- What Is A Biologic?
- Naming Guidelines For Biologics
- Scope of Biologic Naming
- Why Is This Important?
- Role of The Pharmacist
Biological products, also referred to as biologics, are created with biotechnology or another cutting-edge technology.Biological products encompass blood, blood components, somatic cells, gene therapy, tissues, recombinant proteins, and vaccines, and they are typically derived from microorganisms, plant, animal, or human cells.5,6 Biological produc...
As the number of biological products has increased, naming has become increasingly complex. The WHO has long been responsible for international nonproprietary name (INN) assignment. These nonproprietary (generic or proper) names refer to the unique active-ingredient component of the drug which can relate information about the chemical name or, in t...
In the FDA’s 2017 guidance on biologic naming, the agency proposed retrospectively modifying the proper names of already licensed biological products by adding an FDA-designated suffix, but this is no longer the intention of the FDA.1,2 The agency is now proposing the addition of a unique suffix to biological products to new originator/reference, r...
Prior to the implementation of these unique suffixes to the proper names of biological products, it was difficult to fully track adverse events for a specific manufacturer’s biologic if that product shared the same proper name of another biologic.1 The enhanced pharmacovigilance that is expected to result from these unique suffixes will allow for s...
Pharmacists will play a vital role in the education of patients and healthcare providers regarding the new additions of unique suffixes to biological products. These unique suffixes will also allow pharmacists to assume a leadership role in the implementation and reporting of adverse-event information in reference to biological products. Pharmacist...
Jun 7, 2023 · Proprietary and non-proprietary name If a drug does not have a proprietary name, the established name of the drug should be included in the proprietary name field Dosage form and route of ...
2. Generic name – Also called the “non-proprietary name,” it specifies the pharmacological traits of the drug. This is the name used to refer to the underlying compound regardless of the developer. Generic drug manufacturers can use this name after the patent expires on the reference drug (e.g., acetaminophen, paracetamol).
