Through the Center for Drug Evaluation and Research (CDER), a review is conducted by the Division of Medication Error Prevention and Analysis (DMEPA) in consultation with the Division of Drug Marketing, Advertising and Communications (DDMAC) to determine the acceptability of the proposed
proprietary name. (58) The DMEPA conducts the safety review.
The name Gimoti was reportedlydeveloped in compliance with the US FDA's Guidance for Industry, Contents of a Complete Submission for the Evaluation of
Proprietary Names..
Lyxumia is the
proprietary name approved by the European Medicines Agency and other health authorities, concluded the company.
The FDA recently accepted BELBUCA as the
proprietary name for (buprenorphine HCl) buccal film.
According to the company, RayVa is the
proprietary name for its product candidate for the treatment of Raynaud's phenomenon that is secondary to systemic sclerosis, a circulatory disorder affecting the hands and feet and has no approved therapy in the US.
RayVa is the
proprietary name for Apricus' product candidate for the treatment of Raynaud's phenomenon.
A request for
proprietary name review for Triferic will be filed with the New Drug Application (NDA) submission, the company said.
Lyxumia is the
proprietary name approved by the European Medicines Agency (EMA), Australia and Mexico, and submitted to other health authorities for the GLP-1 RA lixisenatide.
Under this application, a New Drug Application (NDA) for UMEC/VI (62.5/25mcg and 125/25mcg doses), with the proposed
proprietary name ANORO ELLIPTA, has been submitted to the Japanese Ministry of Health, Labour and Welfare (MHLW) as a maintenance bronchodilator treatment to relieve symptoms of obstructive airway disorder due to chronic obstructive pulmonary disease (COPD) (chronic bronchitis and emphysema).
British pharmaceutical company GlaxoSmithKline (GSK) (LSE:GSK) (NYSE:GSK) said today that it has submitted a Marketing Authorisation Application (MAA) in Europe for albiglutide, with the
proprietary name EPERZAN.
In addition, the company is preparing to launch lixisenatide in the EU in late Q1 2013 under the
proprietary name Lyxumia.
Both firms have proposed the
proprietary name Anoro Ellipta for umeclidinium bromide.