Teva Pharmaceutical Industries Ltd has been granted tentative approval for the Company's ANDA for Oxycodone Hydrochloride Extended Release Tablets, 10 mg, 20 mg, and 40 mg by the US Food and Drug Administration. Final approval is subjected to the expiration of any applicable exclusivity period enjoyed by another ANDA filer for the same product.
Oxycodone Hydrochloride Tablets are the AB-rated generic equivalent of Purdue Pharma's OxyContin Controlled Release Tablets. The product is indicated for the management of moderate to severe pain. Annual sales of the brand product are approximately $1.23 billion.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 25 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. Close to 90 per cent of Teva's sales are in North America and Europe.