Ja­pan ap­proves use of Nailin cap­sules to treat ony­chomy­co­sis

BioSpectrum (Asia) - - Regulatory News -

Sato Phar­ma­ceu­ti­cal Co., Ltd. has ob­tained mar­ket­ing and man­u­fac­tur­ing ap­proval for the oral an­ti­fun­gal agent, Nailin cap­sules 100mg con­tain­ing the ac­tive in­gre­di­ent fos­ravu­cona­zole L-ly­sine ethanolate (fos­ravu­cona­zole) for the treat­ment of ony­chomy­co­sis in Ja­pan. Sato Pharma con­ducted a phase III clin­i­cal study of the agent in pa­tients with ony­chomy­co­sis in Ja­pan, and after con­firm­ing ef­fi­cacy and safety of the agent in the study, Sato Pharma ap­plied for mar­ket­ing and man­u­fac­tur­ing au­tho­riza­tion in Jan­uary 2017. Fos­ravu­cona­zole, the ac­tive in­gre­di­ent of Nailin cap­sules 100mg, is a new tri­a­zole class oral an­ti­fun­gal com­po­nent dis­cov­ered by Ei­sai. By pro­vid­ing Nailin cap­sules 100mg as a new op­tion for the treat­ment of ony­chomy­co­sis, Sato Pharma and Ei­sai will strive to ful­fil the needs of ony­chomy­co­sis pa­tients and health­care pro­fes­sion­als. Ony­chomy­co­sis is a fun­gal in­fec­tion of the toe­nails or fin­ger­nails that may in­volve any com­po­nent of the nail unit, in­clud­ing the ma­trix, bed, or plate.

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