QuickView: PDUFA date extended to May 2016
In January, an FDA Advisory Committee recommended approval of Titan Pharmaceuticals’ lead product, Probuphine, the first long-acting form of buprenorphine delivered through an implant, as maintenance treatment for opioid addiction. Probuphine uses Titan’s ProNeura long-acting subdermal implant technology. On 19 February, the decision date was delayed until 27 May. Separately, Titan requested a pre-IND meeting for its Parkinson’s disease therapy and recently added a candidate for hypothyroidism to its pipeline.
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