Teva gets FDA OK for Abbott antibiotic generic

Teva’s Clarithromycin extended release tablets are the AB-rated generic equivalent of Abbott’s macrolide antibiotic Biaxin XL Filmtabs. The Abbott branded product has annual sales of approximately $284 million, meaning the generic product could prove to be a lucrative addition to Teva’s product portfolio.

However, the generics giant is currently involved in patent litigation with Abbott concerning this product. Abbott has requested a hearing with a court in connection with its motion for a temporary restraining order, due to be heard in May.

According to the product’s prescribing instructions, Biaxin Filmtab and Biaxin granules are indicated for the treatment of mild to moderate infections in conditions such as pharyngitis/tonsillitis, sinusitis, bronchitis, community-acquired pneumonia and uncomplicated skin and skin structure infections.