AMRX - FDA accepts Amneal Pharmaceuticals NDA for Parkinson's drug IPX203
- The US FDA has accepted Amneal Pharmaceuticals' ( NYSE: AMRX ) NDA for IPX203 (carbidopa/levodopa) for Parkinson's disease.
- The agency has provided an action date of June 30, 2023.
- IPX203 is novel, oral formulation of extended-release carbidopa/levodopa.
- Phase 3 data showed that IPX203 led to significantly more "good on" time, as well as significantly less "off" time, compared to the immediate-release version, even when dosed less often.
- See why Seeking Alpha contributor Bret Jensen rates Amneal ( AMRX ) a hold.
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FDA accepts Amneal Pharmaceuticals NDA for Parkinson's drug IPX203