US FDA Approves Ranbaxy, Zydus Cadila Generics

Indian drugmaker Zydus Cadila has received its first approval from the US FDA, for the antihypertensive Atenolol. The company hopes to launch a further six drugs this year, with US subsidiary Zydus Pharmaceuticals to market Atenolol from April or May this year.

Meanwhile, fellow Indian drug company Ranbaxy has received US FDA clearance to manufacture and market Clarithromycin XL 1000 mg tablets in the US. The product is bioequivalent to Abbott Laboratories' Biaxin XL Filmtab at the 500mg dosage. Clarithromycin is an antibiotic effective against certain infections associated with acute sinusitis, pneumonia and bronchitis.

Ranbaxy will now carry out a launch, pending developments on a US legal challenge filed against Abbott Laboratories. Total annual market sales for oral Clarithromycin are some US$538.9mn in the US, with Abbott's Biaxin accounting for roughly 60% of this total.