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Jack Khattar, president & CEO of Supernus, said the company remain[s] committed to bringing SPN-830 to the market and will work with the FDA to address the issues identified in the CRL and resubmit the NDA

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Compounding pharmacies can compound medications without clinically significant reasons during shortages, but they may still provide compounded formulations with valid medical justifications, such as excipient-free formulations, specific concentration adjustments, or alternate delivery forms