Another stumbling block for Impax Pharma's Rytary

22 January 2013

Impax Pharmaceuticals, the branded products division of Impax Laboratories (Nasdaq: IPXL), revealed on Monday that the US Food and Drug Administration had issued a complete response letter regarding the New Drug Application for Rytary (IPX066), an extended-release capsule formulation of carbidopa-levodopa, a potential treatment for the symptomatic treatment of Parkinson’s disease currently under review in the USA. There was no impact on the firm’s shares as US markets were closed yesterday.

The complete response letter indicates that the FDA requires a satisfactory re-inspection of the company’s facility in Hayward, California, as a result of the warning letter issued in May 2011 before the company’s NDA may be approved due to the facility’s involvement in the development of Rytary and supportive manufacturing and distribution activities. During the assessment of the NDA, the company withdrew the Hayward site as an alternative site of commercial production at launch.

GSK has rights to Rytary outside USA and Taiwan

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