The US Food and Drug Administration has granted tentative approval for Teva Pharmaceutical's ANDA for divalproex sodium delayed-release tablets USP, 125 mg, 250 mg and 500 mg. Final approval of this product is anticipated upon expiration of patent protection for the brand product in January 2008.
Upon final approval, Teva's divalproex sodium delayed-release tablets will be the AB-rated generic equivalent of Abbott's Depakote tablets. This product is indicated for treatment of manic episodes associated with bipolar disorder, prophylaxis of migraine headaches, and as therapy in several types of epileptic disorders, claims a Teva release.
The brand product has annual sales of approximately $813 million.
Teva Pharmaceutical Industries Ltd. is among the top 20 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.