Am­neal asks FDA to ap­prove an­oth­er new for­mu­la­tion of Parkin­son’s com­bo drug 

Af­ter hav­ing al­ready re­ceived FDA ap­proval for a car­bidopa/lev­odopa com­bi­na­tion in 2015, Am­neal Phar­ma­ceu­ti­cals is again at the reg­u­la­tor’s doorstep with an­oth­er new com­bi­na­tion of the decades-old Parkin­son’s treat­ment.

The bio­phar­ma’s pa­pers for IPX203 are now at the FDA, the com­pa­ny said ear­li­er this week.

The New Jer­sey bio­phar­ma al­ready has an ap­proved Parkin­son’s drug known as Ry­tary, an ex­tend­ed-re­lease for­mu­la­tion of the med­i­cine com­bo orig­i­nal­ly known as Sinemet. Im­pax Phar­ma­ceu­ti­cals snagged that ap­proval in 2015 and Am­neal sub­se­quent­ly ac­quired the gener­ics mak­er in 2018.

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