Search results
Apr 12, 2016 · According to the Agency’s review performance goals, FDA will complete its review and communicate a tentative acceptance or non-acceptance about the name within: 180 days for a proposed proprietary name submitted during the Investigational New Drug (IND) phase.
A medicine that goes off-patent becomes a generic medicine. It could be available under an official International non-proprietary name (INPN) or a brand name. The official name or INPN is the generic name of a medicine that is accepted worldwide. Generic medicines in India are mostly available in brand names, i.e. branded generics.
A “non-proprietary” name that is a shorthand version of the drug’s ingredient(s), used for generic drugs. Read this page 5 in the online Merck Manual about drug naming and the difference between generic and trade names. International Nonproprietary Name (INN) An official generic and non-proprietary name given to a pharmaceutical drug.
Jul 28, 2014 · For the first time, the Agency agreed to a process and timelines for notifying applicants of the tentative acceptance or nonacceptance of a proposed proprietary name. These proprietary name review performance goals and timelines are separate from the timelines for approval of underlying new drug applications and biologics license applications.
The proprietary name is the exclusive name the sponsor or distributor assigns to a drug product (see Guidance for Industry (GFI) #240). It is commonly known as the brand name
Jul 17, 2019 · 17 July 2019. Branding pharmaceuticals: drug naming and non-traditional trademarks. In a 2018 rating of the 10 most valuable pharmaceutical brands, Roche® – a Swiss pharmaceutical company, with an estimated brand value of $6.9 billion – was named number one. According to brandirectory.com, Roche is considered more valuable than other ...
Select the incorrect statement concerning OxyContin. a) This is a proprietary name for oxycodone. b) This is a long-acting product. c) This drug is never abused by high school students. d) Recent formulations of this drug make it more difficult to abuse. c) This drug is never abused by high school students.
