Rosenstock J, Wysham C, Frias JP, Kaneko S, Lee CJ, Fernandez Lando L, Mao H, Cui X, Karanikas CA, Thieu VT
Your specialist clinician works with you here to create the best pathway for you, dependent on your health history and your insurance coverage
Damage to the small intestine may result from factors such as bacterial overgrowth, pathogenic bacteria, yeast, parasites, malnutrition, chronic maldigestion, food allergens damaging the villi, reduced stomach acid, toxic irritants, or the use of antibiotics and NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
Step 3: FDA Review Once the NDA is accepted, the FDA assigns a Prescription Drug User Fee Act (PDUFA) target date