Teva gets final FDA OK for generic Lotrel
The US Food and Drug Administration has given Israeli drugmaker Teva Pharmaceutical Industries final approval of its amlodipine besylate/benazepril products in 2.5mg/10mg, 5 mg/10mg; 5 mg/20 mg and 10mg/20mg dosage strengths, AB rated to Novartis' Lotrel and Teva immediately commenced shipping the product.
On May 19, the US District Court for the District of New Jersey granted, in connection with Novartis' pending patent infringement action, an emergency request for a temporary order restraining Teva's launch and scheduled a hearing for May 21, for further proceedings.
Annual sales of the branded product are approximately $1.5 billion in the USA based on IMS Health sales data. As the first company to file an Abbreviated New Drug Application with a Paragraph IV patent certification, Teva has been awarded 180 days marketing exclusivity for this product.
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