Israel's Teva Details New Products for US Market

Leading Israeli generic drugmaker Teva has obtained final US FDA approval on its ANDA for amoxicillin and clavulanate potassium chewable tablets, at the 200mg/28.5mg and 400mg/57mg dosages. The product is a generic version of UK-based drug major GlaxoSmithKline's Augmentin antibiotic, which has annual sales of some US$21mn. The company claims it will begin shipping the product immediately.

Meanwhile, Teva has announced that it has received tentative US FDA approval for its Levofloxacin antibacterial agent injection, a generic version of Ortho McNeil's Levaquin. The company now claims to have tentative or final approvals for the drug at the 250mg, 500mg and 750mg, although an earlier applicant is understood to have filed for the 250mg and 500mg dosages first. Final approval will not now be granted until an ongoing patent litigation in New Jersey is resolved, even though Teva was awarded 180 days' exclusivity on the generic.

Further, Teva has announced that it is to begin selling Savient Pharmaceuticals' Tev-Tropin growth hormone deficiency treatment in the US, via local subsidiary Gate Pharmaceuticals. The New Jersey-based company, which reported a US$4.4mn loss in the third quarter, has developed the drug using its recombinant DNA technology, and is likely to benefit from Teva's strong marketing presence in the US.