About PROCYSBI (Cysteamine Bitartrate) Delayed Release Capsules Sample Clauses


About PROCYSBI (cysteamine bitartrate) delayed-release capsules. PROCYSBI is a cystine depleting agent that is approved in the U.S. for the treatment of nephropathic cystinosis in adults and children ages two years and older. It is contraindicated in patients with a hypersensitivity to penicillamine. The most commonly reported side effects are vomiting, abdominal pain/discomfort, headaches, nausea, diarrhea, anorexia/decreased appetite, breath odor, fatigue, dizziness, skin odor and rash. For additional information on PROCYSBI, including full prescribing information, please visit www.procysbi.com. About QUINSAIR (levofloxacin inhalation solution)QUINSAIR is a proprietary inhaled formulation of levofloxacin, a fluoroquinolone antibiotic, which is approved in the EU and Canada for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with CF. Administration of QUINSAIR with the high efficiency Zirela® Nebulizer System (PARI Pharma GmbH) allows for the delivery of high concentrations of active drug directly to the site of infection in approximately five minutes. QUINSAIR is contraindicated in patients with hypersensitivity to levofloxacin, a history of tendon disorders related to fluoroquinolones, or epilepsy and also patients who may be pregnant or breast feeding. QUINSAIR's safety was evaluated in two double-blind, placebo-controlled studies and an active comparator study in which the most frequently reported adverse reactions were cough/productive cough, dysgeusia and fatigue/asthenia.FORWARD-LOOKING STATEMENTSThis press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are indicated by words or phrases such as “believes,” “expects,” “anticipates,” “estimates,” “plans,” “intends,” “continuing,” “ongoing,” “projected,” “potential” and similar words or phrases and relate to future events, including statements regarding: PROCYSBI and QUINSAIR sales growth and territorial expansion, Raptor's projected global net revenue, PROCYSBI's projected revenue growth, Raptor's projected Non-GAAP operating expenses, the timing of a decision on marketing approval of PROCYSBI in Canada, the degree of competitive protection issued patents on QUINSAIR may offer Raptor, time to market for QUINSAIR in Canada, Raptor’s expectations regarding discussions with the FDA regarding MP-376 as a treatment for Pseudomonas aeruginosa in CF, Raptor’s plans regarding initiation of clinical studies, exploration of ...