If a drug is approved via this expedited pathway, the follow…

If a drug is approved via this expedited pathway, the following will be included in the Indication section of the approved labeling: “This indication is approved under ___________________, based on [insert surrogate endpoint]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.”

According to the website for this product, “DEPLIN®, a presc…

According to the website for this product, “DEPLIN®, a prescription product, is specially formulated to meet the nutritional needs of people with depression and can be used with your current antidepressant. DEPLIN® capsules contain L-methylfolate, an active form of folate. Folate, which is one of the body’s essential B vitamins, helps the brain naturally improve your mood.” DEPLIN is a: