Noven Pharmaceuticals, Inc announced that the US Food and Drug Administration (FDA) has approved Stavzor (valproic acid delayed release capsules) in 125 mg, 250 mg and 500 mg strengths.

Stavzor is approved for the treatment of manic episodes associated with bipolar disorder, as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures, and for prophylaxis of migraine headaches.

The product will be marketed and sold by Noven Therapeutics, LLC, Noven's specialty pharmaceutical subsidiary, and is expected to be available in pharmacies in the second half of August.

Stavzor soft gel capsules are small (up to 40 per cent smaller than Depakote and Depakote ER tablets at the 500 mg dosage strength) and easy to swallow, with an advanced enteric technology designed to reduce reflux and gastric irritability. Banner Pharmacaps Inc, Noven's development partner for this product, developed Stavzor using its EnteriCare enteric soft gelatin capsule delivery system, and submitted the Stavzor New Drug Application to the FDA.