FDAnews Drug Daily Bulletin

Ranbaxy Laboratories has received final FDA approval to manufacture and market generic Biaxin for oral suspension, making it the first generic company to receive approval for this product, the company announced.

Abbott Laboratories’ Biaxin (clarithromycin) for oral suspension, 125- and 250-mg/mL, is an antibiotic indicated for treating tonsillitis, community-acquired pneumonia, uncomplicated skin and skin structure infections, and disseminated mycobacterial infections, Ranbaxy said. The drug had annual sales totaling $25.3 million during the 12-month period ending in June, according to IMS Health data.

“This approval further expands our product portfolio of affordable generic alternatives and will be shipped immediately to all classes of trade,” Jim Meehan, vice president of sales and distribution for Ranbaxy Pharmaceuticals, said.