Ranbaxy cleared to market generic anti-infective

The FDA has determined that Ranbaxy’s formulation can be expected to have the same therapeutic effect as an equivalent dose of Biaxin XL filmtab extended release tablets 500mg of Abbott Laboratories.

Clarithromycin XL tablets are indicated for the treatment of mild to moderate infections caused by susceptible strains of the microorganisms in a number of conditions including pharyngitis/tonsillitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, and skin and skin structure infections.

“This 1000mg dosage form represents a formulation that offers the convenience of a single dose tablet versus Abbott’s [the] currently available regimen of two tablets of 500mg dosed on a once daily basis,” said Dipak Chattaraj, president of Ranbaxy.

Ranbaxy has already begun preparing for an expected product launch in May 2005. In late 2004, the company initiated action against Abbott concerning the Clarithromycin XL patents in Illinois.