Titan Pharmaceuticals Inc (TTNP)

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Titan Pharmaceuticals Announces Confirmation of Meeting With FDA Regarding Probuphine


SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 09/26/13 -- Titan Pharmaceuticals, Inc. (OTCBB: TTNP) today announced that the U.S. Food and Drug Administration (FDA) has granted the request for a meeting to discuss Probuphine®. The meeting is scheduled for November 19, 2013. The FDA has designated this as a Type C meeting and has requested the submission of briefing materials by October 7, 2013.

The goal for this meeting is to understand more fully the issues raised in the April 2013 Complete Response Letter (CRL) to the New Drug Application (NDA) for Probuphine for the maintenance treatment of opioid dependence in adults, review and discuss the available data from the Probuphine studies conducted to date and gain further clarity regarding the regulatory path forward for Probuphine. Following the meeting, written minutes will be distributed by the FDA and Titan will then provide an update on the meeting and the regulatory path forward for Probuphine.