Dr. Reddy's Laboratories received approval for its generic version of GSK’s Zofran, which is indicated for the prevention of nausea and vomiting related to cancer treatment. The company’s Ondansetron Hydrochloride tablets, 4 mg, 8mg, 16 mg, and 24 mg was also awarded a 180-day period of marketing exclusivity, as the first company to file the ANDA.
"We are obviously pleased with the final approval of our generic version of Zofran with 180-days of marketing exclusivity,” says GV Prasad, vice-chairman and CEO. Dr. Reddy's reports that Zofran has annual IMS sales of approximately $639 million.
“With six product introductions to date in the current year, we are making good progress in building a sustainable base generics business with potential upsides in the U.S. in the medium term,” points out Prasad. “This reaffirms our commitment to developing one of the largest pipelines in the U.S. generic industry."