Ranbaxy, Lupin get FDA approvals for antibiotics
Ranbaxy and Lupin have received approval to make and market generic tetracycline antibiotic and cefdinir respectively.india Updated: Jun 02, 2006 17:53 IST
Indian drug maker Ranbaxy Laboratories Ltd has received approval from the US Food and Drug Administration to make and market generic tetracycline antibiotic doxycycline in the tablet form.
The drug is the generic equivalent of Bioglan Pharmaceutical Co's Adoxa, which had annualised sales of $57.2 million, Ranbaxy said in a statement on Friday.
The approval is for the 50mg, 75mg and 100mg dosages.
Shares in Ranbaxy, India's second-most valuable drug maker, rose more than 5 per cent to Rs 424.05 in a firm Mumbai market.
Lupin Ltd received approval for making and marketing antibiotic cefdinir in the oral suspension form, the FDA Web site showed. It had earlier received approval for the capsule.
Cefdinir is the generic equivalent of Abbott Laboratories Inc's Omnicef.
Cefdinir is a third generation cephalosporin to treat bacterial infections. Sales of Omnicef suspension were $137 million last year and combined sales for capsules and suspensions were $634 million, Lupin said in a statement.
Shares in Lupin were more than 1 percent lower at Rs 986.95.
The company has a total of 12 abbreviated new drug applications that have been approved by the US FDA.