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Ranbaxy gets USFDA nod for Ofloxacin
June 20, 2003 12:55 IST
Ranbaxy Laboratories on Friday said it has received tentative approval from US Food and Drug Administration to manufacture and market Ofloxacin, the generic version of Ortho Mcneil Pharmaceutical Inc's Floxin.
The company has received FDA approval for 200mg, 300mg and 400mg tablets of anti-biotic Ofloxacin, which is used for treating adults with mild to moderate infections caused by susceptible strains of designated micro-organisms.
In 2002, the sales for Ofloxacin tablets totalled $31.3 million in the US market, a company statement said in New Delhi.
The product is one of the first oral quinolones experiencing patent expiration having the most extensive clinical record of safety and efficacy in the quinolone class of anti-biotic.
It will be marketed by the sales team of Ranbaxy Pharmaceutical Inc, Ranbaxy's US subsidiary, and is expected to be available through wholesellers and other distribution outlets in the US at the time of patent expiration.