Complete Response Letter for IPX 203 for treatment of Parkinson's disease.-Amneal Pharma
The FDA has issued a complete response letter (CRL) to Amneal Pharmaceuticals for IPX 203, an oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules designed for the treatment of Parkinson’s disease.
Reasons behind the decision were not based on efficacy or manufacturing for the agent, but rather established safety for an ingredient of the therapy.
In its release, the agency noted that the pharmcokinectic data for the safety of one ingredient, levodopa, was sufficient; however, it felt it needed additional data for the second ingredient, carbidopa. Amneal plans to work closely with the FDA to address the comments and align on the best path forward.
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