On 6/30/2013, FDA approved Noven Pharmaceuticals Brisdelle (paroxetine) for the treatment of vasomotor symptoms (hot flashes). This 505(b)(2) approval is notable since it is the first non-hormonal product product approved for this indication. But from a regulatory point of view, it is even more interesting – FDA went against a 10-4 Advisory Committee vote against approval. I have previously posted a comment on the Advisory Committee outcome. In that posting I noted that the FDA had stated that the proposed product failed to meet the endpoints spelled out in the guidance for drugs to treat this indication. The approval documents are not posted at this writing, so it is uncertain what the FDA reasoning might be. The FDA apparently heeded the concern of the Advisory Committee – the Noven product was approved with a boxed warning cautioning the user could face increased risk of suicide.
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