Posted by Michael Wonder on 09 Feb 2024
Amneal announces complete response resubmission for IPX203 new drug application
8 February 2024 - Amneal Pharmaceuticals today announced that it has provided a complete response resubmission to the US FDA for IPX203, a novel, oral formulation of carbidopa/levodopa extended-release capsules for the treatment of Parkinson’s disease.
The original NDA for IPX203 resulted in a complete response letter from FDA.
