(cysteamine bitartrate) delayed-release capsules
This clarifies our near-term priorities, which are to maximize the reach of PROCYSBI
in nephropathic cystinosis, further the development of RP103 in Huntington's and mitochondrial diseases, prepare for QUINSAIR'S launch and initiate at least one trial in nontuberculous mycobacteria or bronchiectasis.
Food and Drug Administration (FDA) has approved PROCYSBI
(TM)(cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children 6 years and older.
The company offers PROCYSBI
, a delayed-release capsule, which is used for the management of nephropathic cystinosis in adults, as well as in six years and older children in the United States, in the 28 member states of the European Union, Norway, Liechtenstein, and Iceland.
Chairman of the Board of Directors, said, "Julie is a proven leader and has been instrumental in the launch and commercialization of Raptor's first product, PROCYSBI
June 12, 2014 /PRNewswire/ -- Decision Resources Group finds that three therapies, Teva's Huntexil, Auspex's SD-809 and Raptor's Procysbi
, will likely receive regulatory approval for Huntington's disease (HD) in the United States and the EU5 markets (Germany, France, Italy, Spain and United Kingdom) during the 2013-2023 study period.
For Q4 2013, Raptor recorded net product sales for PROCYSBI
Julie Anne Smith, Executive Vice President Strategy and Chief Operating Officer, said, "We are seeing strong PROCYSBI
demand from both RaptorCares pre-registered patients, and new patients not previously identified.
Raptor Pharmaceutical) announced that it has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP), recommending marketing authorization for PROCYSBI
25mg and 75mg gastro-resistant hard capsules, cysteamine (as mercaptamine bitartrate) for the treatment of proven nephropathic cystinosis.
Raptor Pharmaceutical) announced that the Office of Orphan Product Development at the Food and Drug Administration (FDA) has granted the Company orphan drug exclusivity for PROCYSBI
(cysteamine bitartrate) delayed-release capsules for the management of nephropathic cystinosis patients of the age six and above.
This team has invested in 34 pharmaceutical and medical device products through two HC Royalty investment funds including LYRICA,Oracea, Cetrotide, and PROCYSBI
(TM), an orphan drug recently approved by the FDA for the treatment of nephropathic cystinosis.
Conference Call Raptor has scheduled an investor conference call and webcast to discuss the FDA approval of PROCYSBI
at 4:30 p.