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A brand (proprietary) name is not essential to obtain an NOC/DIN for a drug submission. An NOC/DIN can be issued under the drug's common/proper name.
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Dec 15, 2023 · How are INNs chosen? A group of experts at the WHO called the INN Expert Committee carefully selects INNs based on several criteria: Uniqueness: The name should be unique and not resemble existing drug names or trademarks to avoid confusion.
Following internal and external stakeholder consultations and analysis of related issues, Health Canada has decided that biologic drugs, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix.
Mar 25, 2024 · 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).
Feb 14, 2019 · All biologic drugs, including biosimilars, reference biologics and innovator biologics, would receive a unique, meaningless 4-letter suffix appended to the non-proprietary name. Products sharing the same non-proprietary name would be distinguished by the suffix.
Generic and brand names must be unique to prevent one drug from being mistaken for another when drugs are prescribed and prescriptions are dispensed. To prevent this possible confusion, the FDA must agree to every proposed brand name.
