Banner wins approval for valproic acid softgel capsules

Banner’s valproic acid delayed release soft gelatin capsules is approved for use in the treatment of manic episodes associated with bipolar disorder, as monotherapy and adjunctive therapy in multiple seizure types, and for prophylaxis of migraine headaches.

The drug has a similar pharmacokinetic profile to Abbott Laboratories Depakote delayed release tablets. Banner has partnered with Noven Pharmaceuticals, which will market and sell this product under the brand name of Stavzor through its Noven Therapeutics subsidiary.

Stavzor is said to be the first pharmaceutical product to utilize Banner’s patent-pending EnteriCare technology. This innovative concept allows for the direct delivery of the active pharmaceutical ingredient without encountering the challenges typical to enteric coated softgels.

With EnteriCare, the enteric features reside within the shell; thereby avoiding the propensity of coated softgels to crack and chip, potentially compromising the integrity of the functional coating.