New Delhi: Drug firms Lupin and Dr Reddy’s Laboratories on Wednesday said they have received US health regulator’s approval to market generic levofloxacin in the American market used for treating bacterial infections.
The United States Food and Drug Administration (USFDA) on Tuesday allowed for the first time sale of generic levofloxacin that opened the doors for 12 firms, including Aurobindo Pharma, Dr Reddy’s Laboratories, Glenmark Generics, Lupin and Wockhardt.
Lupin and Dr Reddy’s Laboratories said the approval from the USFDA was for levofloxacin tablets in the strengths of 250 mg, 500 mg and 750 mg.
Wockhardt had on Tuesday said it has received USFDA approval for the same strength of levofloxacin tablets. On the other hand, Strides Arcolab said it got approval for Levofloxacin injections in strengths of 25 mg/mL, packaged in 500mg/20 mL and 750mg/30 mL single-use vials.
According to IMS Health data, the market for Levaquin brand is estimated to be nearly $1.1 billion for 12 months ended March 2011.
Levofloxacin, which is a generic version of Levaquin marketed in the US by Ortho Mcneil (Johnson & Johnson), is used for treating a broad spectrum of bacterial infections.
The USFDA allowed generic tablets, oral solution, and injectable solution dosage forms of Levofloxacin to be sold in the US market after the patent expiry.