New Delhi: Drug firm Wockhardt today said it has received US health regulator’s approval to market Levofloxacin tablets, used for treating bacterial infections, in the American market.
The company has received final approval from US Food and Drug Administration (USFDA) for Levofloxacin tablets in strengths of 250 mg, 500 mg and 750 mg, Wockhardt said in a statement.
Besides Levofloxacin tablets, the company has also launched Donepezil tablets and Venlafaxine extended-release capsules in the US market recently.
“After Donepezil tablets on 31 May and Venlafaxine extended-release capsules on 1 June, this is our third new product launch in the United States, within the past twenty-one days,” Wockhardt Chairman Habil Khorakiwala said.
“Each of these products was launched on the date the generic market opportunity opened. While business on the existing products has been growing, it is the steady infusion of new products that has enabled us to put our US business on a path of rapid growth,” he added.
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.
Donepezil, a generic version of Eisai’s brand Aricept is used in treating Alzheimer’s disease while Venlafaxine extended release capsule, a generic version of Pfizer’s Effexor, is an antidepressant drug.
“According to IMS, the combined brand sales of all three products, in the United States market, is over USD 6 billion,” the company said.
Shares of Wockhardt today closed at Rs 349.70 on Bombay Stock Exchange, down 0.64% from its previous close.