You may have already seen journal advertisements for Deplin (www.deplin.com), a formulation of L-methylfolate produced by a company called Pamlab LLC. Touted as an “antidepressant food,” Pamlab claims it is “a first choice in depression augmentation.”

Topics: Antidepressants

Suddenly, psychopharmacology has apparently become “all Seroquel, all the time.” AstraZeneca’s atypical antipsychotic (generic name, extended release quetiapine), which already had FDA approval for schizophrenia and bipolar mania, recently won approval for bipolar depression, and is now pushing for indications in depression and generalized anxiety disorder (GAD).

Dr. Kesselheim, you and your colleagues just published an intriguing paper on generic medications (Kesselheim AS et al., JAMA 2008;300(21):2514-2526). I’d like to start by asking you to explain the generic approval process. What does the FDA do to give its seal of approval to generic medications?