From rxpgnews.com
Ranbaxy gets US approval for anti-infective drug
By RxPG News Service,
Dec 15, 2006 - 2:10:51 AM
New Delhi, Dec 14 - Indian pharma major Ranbaxy Laboratories Ltd -, has received approval from the US Food and Drug Administration - to manufacture and market anti-infective generic drug Cefprozil.
'The Office of Generic Drugs of the US FDA has determined Ranbaxy formulation to be bio-equivalent and has the same therapeutic effect as that of the reference listed drug Cefzil - of Bristol Myers Squibb Company Pharmaceutical Research Institute,' the company said in a statement Thursday.
With this approval Ranbaxy will be able to manufacture and market Cefprozil tablets of 250 mg and 500 mg dosage in the US.
'Ranbaxy is pleased to be granted approval for Cefprozil tablets which represents yet another addition to our ever-growing product portfolio of anti-infectives that will be available as an affordable generic alternative to the brand equivalent,' said Jim Meehan, vice president of sales and marketing of Ranbaxy Pharmaceuticals Inc. -, the US subsidiary of Ranbaxy.
Cefprozil tablets would be produced in Ranbaxy's manufacturing facility at Dewas, Madhya Pradesh, and would 'be introduced in the US market in early 2007 during the height of the respiratory season'.
Cefprozil is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in certain conditions, including: pharyngitis/tonsillitis, otitis media, acute sinusitis, secondary bacterial infection of acute bronchitis and acute bacterial exacerbation of chronic bronchitis and uncomplicated skin and skin-structure infections.
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