BALTIMORE — Lupin Pharmaceuticals announced today that it has launched its generic gatifloxacin ophthalmic solution 0.5%. Lupin had earlier received final approval from the Food and Drug Administration to market a generic version of Allergan's Zymaxid ophthalmic solution, 0.5%, which is indicated for the treatment of bacterial conjunctivitis.
Zymaxid had annual U.S. sales of approximately $62.3 million. As the first applicant to file an ANDA for Zymaxid, Lupin will be entitled to 180 days of marketing exclusivity.
Commenting on the approval, Nilesh Gupta, managing director Lupin Limited, 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."