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Additionally, the company received US FDA market clearance for Trientine Hydrochloride in 250mg capsules in 100 count bottles, which is the company's AB rated generic to Valeant Pharmaceuticals brand Syprine.
Therapy involves lifelong administration of either D- penicillamine or trientine hydrochloride; both of these drugs remove copper deposits by binding to the copper which is removed from the body via the urine.
(NYSE: TEVA) (TASE: TEVA) has launched a generic version of Syprine (trientine hydrochloride) capsules, 250 mg, in the US, the company said.
Trientine hydrochloride is used in the treatment of penicillamine-intolerant patients with Wilson's disease, a genetic disease that prevents the body from removing excess copper and potentially causing life-threatening organ damage.
Clinical experience with trientine hydrochloride is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined.
M2 PHARMA-April 5, 2017-Kadmon Submits Second US Abbreviated NDA Filing for Trientine Hydrochloride
KD034is the company's trientine hydrochloride formulation for the treatment of Wilson's disease, a rare genetic liver disorder, for patients who are intolerant of penicillamine.
This second ANDA is for Kadmon's generic version of trientine hydrochloride in blister packaging that offers room temperature storage, which the company believes has the potential to address shortcomings of currently available trientine hydrochloride formulations.