A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
The FDA is warning a pharmacy in Vancouver for continuing to sell its unapproved clobazam to U.S. patients despite the agency’s approval of Lundbeck’s Onfi in 2011. Mark’s Marine Pharmacy also was warned over letters it sent to U.S. patients and physicians, informing them that they can continue to receive clobazam even if it will not be used to treat Lennox-Gastaut syndrome, which is the only FDA-approved indication for Onfi (clobazam). Drug Industry Daily