Pfizer’s Novarsc has $2.8 billion in annual sales. Mylan is suing the FDA, claiming it has 180 days exclusivity for generic Norvasc.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has obtained US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA)for Amlodipine Besylate tablets, 2.5 mg, 5 mg and 10 mg. and will begin shipments shortly. Amlodipine Besylate is the AB- rated generic equivalent of Pfizer Inc.’s (NYSE:PFE; LSE:PFZ) Norvasc for treating hypertension, chronic stable angina and vasospastic angina.
Teva noted that Mylan Laboratories Inc. (NYSE:MYL) sued the FDA arguing that its 180-day exclusivity for generic Norvasc blocked other final approvals until September 2007. On the basis of IMS sales data, Norvasc sales totaled $2.8 billion for the twelve months through March.
Published by Globes [online], Israel business news - www.globes.co.il - on July 1, 2007
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