Durlobactam has been approved as the international nonproprietary name
Nexavar[R] Tablets 200 mg (Nonproprietary Name
: Sorafenib Tosylate Tablets) specific drug use investigation for unresectable hepatocellular carcinoma.
announce that results from two phase 3 clinical trials (a 2-week double-blind placebo-controlled phase 3 trial and an open-label single-arm 52-week long-term phase 3 trial) for the bile acid transporter inhibitor "GOOFICE 5mg Tablet" (nonproprietary name
: elobixibat hydrate; development code: AJG533, hereinafter "elobixibat") have been published in The Lancet Gastroenterology & Hepatology(1)) a journal of The Lancet which is one of the world's most influential medical journals.
In August, the FDA announced draft guidance proposing that all biopharmaceutical products (originator and biosimilars) would have a nonproprietary name
that includes a suffix of four lowercase letters that is devoid of meaning.
Generic drugs are labeled with the name of the manufacturer and the adopted name (nonproprietary name
) of the drug.
Both traditional drugs and biologies typically have two names: a brand name--often called a proprietary name--and a nonproprietary name
. The nonproprietary name
reflects certain characteristics of the drugs such as chemical structure or pharmacological properties.
WHO is responsible for ensuring there is a single name acceptable worldwide for each approved active pharmaceutical substance, known as an international nonproprietary name
Food and Drug Administration's Center for Biologies Evaluation and Research and the United States Adopted Names Council as the nonproprietary name
for Aastrom's investigational cell therapy product.
Building on current requirements for doctors to prescribe medicines by their international nonproprietary name
(INN) rather than a brand name, the new directive means that pharmacists have to offer patients the cheapest available version of the medicine being prescribed.
The USAN Council (tri-sponsored by the American Medical Association (AMA), the United States Pharmacopeia Convention (USP), and the American Pharmacists Association (APhA), aims for global standardization and unification of drug nomenclature and related rules to ensure that drug information is communicated accurately and unambiguously, working closely with the International Nonproprietary Name
(INN) program of the World Health Organization, and various national nomenclature groups.
Calcipotriol is the international nonproprietary name
of calcipotriene, which is marketed in the United States as Dovonex by Westwood Squibb Pharmaceuticals.