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Ranbaxy Labs get US FDA approval for drug
September 16, 2003 18:31 IST
Last Updated: September 16, 2003 18:47 IST
Ranbaxy Laboratories on Tuesday said it had received approval from US Food and Drug Administration to market a semi synthetic cephalosporin Panixine DisperDose, a generic version of Ceph International Corp, Keflex.
The company has received approval for Cephalexin for oral suspension 125 mg and 250 mg total market for which had been valued at $32 million in US.
Cephalexin represents the second most prescribed anti-infective agent in US for clinical indications such as respiratory tract infections, skin and skin structure infections, bone infections and genit-urinary tract infections.
This new dosage form of Cephalexin will be especially beneficial to patients who cannot swallow solid dosage forms and as alternative to the oral suspension Cephalexin, a Ranbaxy statement said.
Panixine DisperDose will be distributed by Ranbaxy Brand Promotion Division in US under Ranbaxy label.
Commenting on the approval, Ranbaxy Pharmaceuticals Inc, president Dipak Chattaraj said: "This addition to the already extensive line of anti-infectives available from Ranbaxy once again demonstrates the company's commitment to this therapeutic category through this value added dosage form that will provide a worthwhile contribution to patient care and to the overall US healthcare system."