The FDA failed to approve Titan Pharmaceutical's new drug application for Probuphine on April 30th. Probuphine is a novel implant to aid those who are addicted to opioids in eliminating their dependency and allowing them to resume normal and productive lives. The current hue and cry by your administration is to emphasize finding new ways to combat this addiction while reducing the risk of diversion of these medications, as well as accidental ingestion of these medications by, and grave harm to those for which they are unintended, including innocent children. Probuphine met the criteria for approval which the FDA themselves established- the ADCOM on March 21st rendered a positive vote of 10-4-1- yet the drug was not approved. Reasons given by the FDA for non-approval are disingenuous.
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