FDA's Lexapro For Teens Approval Creates Doubt About FDA Approval Process

the FDA has once again gone and approved a drug for use in kids with only one positive clinical trial, a trial that remains unpublished, despite the FDA's longstanding policy of requiring two positive clinical trials of a drug for approval. Both the FDA and Forest might claim there were two positive studies, but only the first study referred to on the drug's package insert was of Lexapro. The second was of Celexa. Yes, the FDA is now letting pharma companies obtain approval of drug's using data from other, similar drugs.