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news.The FDA has issued an approvable letter for Noven Pharmaceuticals' Stavzor 125mg, 250mg and 500mg, for the treatment of manic episodes associated with bipolar disorder, and adjunctive therapy in multiple seizure types, including epilepsy and prophylaxis of migraine headaches.
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The FDA has requested certain non-clinical information, including additional in vitro dissolution data, as a condition to final approval. The FDA has not requested additional human studies or clinical data.
Because the new drug application (NDA) for Stavzor delayed release capsules references Abbott Laboratories’ Depakote product, final approval is also subject to the expiration of any applicable exclusivity periods benefiting Depakote. Based on receipt of the approvable letter, interaction with Banner Pharmacaps (the NDA holder and developer of the product), and its understanding of Depakote exclusivity, Noven continues to expect Stavzor final approval, at the latest, by the end of July 2008.
Based on receipt of the approvable letter, interaction with Banner Pharmacaps (the NDA holder and developer of the product), and its understanding of Depakote exclusivity, Noven continues to expect Stavzor final approval, at the latest, by the end of July 2008.
Robert Strauss, Noven’s president, CEO & chairman, said: “We are now working with Banner to satisfy the conditions to final approval as expeditiously as possible. Banner has advised that it expects to respond to the FDA’s requests in the coming weeks. Concurrently, the Noven/JDS team has begun launch and production planning in anticipation of a 2008 launch of Stavzor.”