Still not happy, FDA sticks Supernus with CRL again

9 April 2024

The US regulator has once more rebuffed efforts on the part of Supernus Pharmaceuticals (Nasdaq: SUPN) to register its Parkinson’s disease candidate SPN-830.

It is the second time that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) related to the investigational apomorphine infusion device.

Supernus wants to market the product for the continuous treatment of motor fluctuations in Parkinson’s.

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