Teva gets generic Omnicef OK, starts shipping

20 May 2007

The US Food and Drug Administration has granted approval for Israeli firm Teva Pharmaceutical Industries' Abbreviated New Drug Applications to market its generic versions of Abbott Laboratories' antibiotic Omnicef (cefdinir) capsules, 300mg, and for oral suspension, 125mg/5ml and 250mg/5ml. Teva says it has commenced shipment of these products.

Omnicef capsules and Omnicef suspension had annual sales of around $325.0 million and $533.0 million, respectively, in the USA based on IMS Health data.

Teva is currently in patent litigation concerning this product in the US District Court for the Northern District of Illinois, in a suit was brought against the firm in March involving Abbott's US Patent No 4,935,507. On May 3, the District Court denied Abbott's request for a preliminary injunction against Teva with respect to its cefdinir products. The Court found that Abbott had not proven a likelihood of success on its allegations of infringement of Teva's products, the Israeli firm noted.

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