Teva Pharmaceutical Industries Ltd. announced that the US Food and Drug Administration has granted tentative approval for the company's ANDA for Famciclovir tablets, 125 mg, 250 mg and 500 mg.
According to a Teva press release, the final approval of this application is anticipated on August 24, 2007, upon expiry of the mandatory stay of approval associated with patent litigation related to this application.
The brand product had annual sales of approximately $190 million for the twelve months ended March 31, 2007, based on IMS sales data.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 76 percent of Teva's sales are in North America and Europe.