The FDA approved a generic version of Ellence injection and granted a tentative approval of Revatio, both made by Pfizer.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has obtained two approvals from the US Food and Drug Administration (FDA): Epirubicin Hydrochloride Injection, a generic version of Pfizer Inc. (NYSE:PFE; LSE:PFZ) Ellence Injection; and a tentative approval for Sildenafil Citrate Tablets, a generic version of Pfizer's Revatio Tablets.
Teva will begin deliveries of Epirubicin Hydrochloride Injection immediately. The company plans to begin deliveries of Sildenafil Citrate Tablets after obtaining final approval of the drug when the Revatio patent expires in March 2012.
IMS data indicate that Ellence is a supplementary therapy for patients with evidence of axillary node tumor involvement following resection of primary breast cancer, had $60 million in US sales for the twelve months through 2007.
Published by Globes [online], Israel business news - www.globes.co.il - on August 12, 2007
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