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.”
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?
Dr. Aiken is the Editor in Chief of The Carlat Psychiatry Report; director of the Mood Treatment Center in North Carolina, where he maintains a private practice combining medication and therapy along with evidence-based complementary and alternative treatments; and Assistant Professor NYU Langone Department of Psychiatry. He has worked as a research assistant at the NIMH and a sub-investigator on clinical trials, and conducts research on a shoestring budget out of his private practice. Follow him on Twitter and find him on LinkedIn.