HYDERABAD, India, Dec. 27 (UPI) -- Indian firm Dr. Reddy's said Wednesday it has been approved for U.S. sales of approval of a generic version of GlaxoSmithKline's Zofran.
The generic drug maker said the Food and Drug Administration has approved its ondansetron hydrochloride tablets in 4 mg, 8mg, 16 mg and 24 mg strengths.
The approval was won Dr. Reddy's 180 days' market exclusivity, for being the first company to gain approval of a generic formulation of the top-selling GSK product.
"We are obviously pleased with the final approval of our generic version of Zofran with 180-days of marketing exclusivity," said GV Prasad, vice-chairman and CEO of Dr. Reddy's. "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. This reaffirms our commitment to developing one of the largest pipelines in the U.S. generic industry."
Dr. Reddy's estimated annual sales of Zofran at approximately $639 million, based on IMS Health data.
The company also noted that the approval follows an order by the United States Court Of Appeals for the D.C. Circuit denying rival Apotex's request that FDA not approve Dr. Reddy's product, pending a determination of its motion for a preliminary injunction.
