Lupin has launched its generic Gatifloxacin ophthalmic solution, 0.5 per cent. Lupin had earlier received final approval from the United States Food and Drugs Administration (US FDA) to market a generic version of Allergan’s Zymaxid ophthalmic solution, 0.5 per cent.
Lupin’s Gatifloxacin ophthalmic solution 0.5 per cent is the generic equivalent of Zymaxid ophthalmic solution of Allergan and is indicated for the treatment of bacterial conjunctivitis. Zymaxid ophthalmic solution, 0.5 per cent, had annual US sales of approximately $ 62.3 million (IMS MAT Jun 2013). Lupin was the first applicant to file an ANDA for Zymaxid ophthalmic solution and as such will be entitled to 180 days of marketing exclusivity.
Commenting on the approval, Nilesh Gupta, Managing Director, Lupin said, “Having received approval earlier, we are happy to now launch this product. The product is the first of the ophthalmic products that Lupin is bringing to the market and bears testimony to our continued commitment to serving our customers and patients by bringing high quality, affordable medicines.”
EP News Bureau – Mumbai