Titan Pharmaceuticals: Late last night, Titan received a complete response letter (rejection) from the FDA for their opiod addiction implant, Probuphine. This is an interesting case because Titan had received a FDA panel recommendation less than a month ago (vote was 10-4-1 in favor) to approve the drug. Despite this, the FDA has requested additional data from the company. It is not common that the FDA essentially contradicts itself ruling again the recommendation of a FDA panel but there have been prior cases of this such as Orexigen’s obesity drug Contrave and Mannkind’s inhaled insulin drug Afrezza.

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