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The agency said the company failed to meet CGMP requirements, including implementing and adhering to its risk-based corrective and preventive action (CAPA) procedures
The intranasal spray formulation provides additional scientific value by allowing laboratories to investigate formulation stability, spray consistency, peptide integrity, physicochemical properties, analytical reproducibility, and intranasal delivery system performance
Mild fatigue during titration
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The prescribing provider sets the dose and adjusts based on clinical response throughout the cycle
That gap should make you pause
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