Teva has won another important approval from the US Food and Drug Administration (FDA). On Friday, Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA; TASE:TEVA) announced that the FDA had granted tentative approval for the its ANDA (abbreviated new drug application) for Oxycodone Hydrochloride Extended Release Tablets, 10 mg, 20 mg, and 40 mg.
Teva said that final approval was subject 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.
According to Teva, annual sales of the brand product are approximately $1.23 billion.
Teva started to sell Oxycodone 80mg in March this year. Teva had six months exclusivity for the 80mg dosage.
Teva shares closed 1.28% up at $29.18 in New York on Friday, giving it a market cap of nearly $18 billion.
Published by Globes [online], Israel business news - www.globes.co.il - on December 12, 2004