Amneal gets US FDA approval for Crexont

9 August 2024

The US Food and Drug Administration (FDA) has approved Crexont (carbidopa and levodopa; formerly IPX2023) extended-release capsules for the treatment of Parkinson’s disease (PD), from US drugmaker Amneal Pharmaceuticals (Nasdaq: AMRX), whose shares closed on 14.1% at $7.77 on the news yesterday.

Crexont is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release (IR) granules and extended-release (ER) pellets. Amneal expects to make the drug available to patients in the US in September 2024.

The news is a positive result for Amneal, given that last year the FDA issued a complete response letter (CRL) regarding the New Drug Application (NDA) for IPX203 in the treatment of Parkinson’s disease, requesting unspecified additional information. Pharma analytics firm GlobalData previously forecast that IPX-203 will generate global sales of $118 million by 2029.

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