FDA rejects Amneal's extended-release Parkinson's treatment, seeking more safety data
The FDA has rejected specialty pharma and generics maker Amneal Pharmaceuticals’ extended-release capsule for Parkinson’s disease, which combines two drugs that have long been used to treat the neuro condition.
The drug, IPX203, is a new formulation of levodopa and carbidopa. In the complete response letter, the FDA acknowledged an “adequate scientific bridge” for the safety of levodopa based on pharmacokinetic studies, but said safety was not adequately established for carbidopa, according to Amneal.
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