The US Food and Drug Administration has granted tentative approval for the Teva’s ANDA for zaleplon capsules, 5 mg and 10 mg.
Upon final approval, Teva’s zaleplon capsules will be the AB-rated generic equivalent of Jones Pharma Inc.’s Sonata capsules, a product indicated for short term treatment of insomnia. The brand product has annual sales of approximately $121 million, claims a company release.
The final approval in the case or expiry of the mandatory stay is expected in December 2007.
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.