In June 2005, the FDA granted tentative approval for the company's ANDA for ondansetron HCl
ODT in 4 mg and 8 mg strengths.
Tablets are the generic version of GlaxoSmithKline's Zofran(R) Tablets.
Ondansetron HCl is a generic version of the most widely used antiemetic drug for patients undergoing chemotherapy or surgery.
Paclitaxel, Ondansetron HCl and other oncological APIs are manufactured at the company's FDA-approved, cGMP site in Taiwan, where multiple high-potency manufacturing suites are built together with an ultra-pure water system for the use of injections.
Total annual sales of Ondansetron HCl
Tablets and Ondansetron Orally Disintegrating Tablets, including brand and generic sales, are approximately $750 million and $350 million, respectively, in the U.
Spectrum and Par believe that Spectrum was the first to file an ANDA and is entitled up to 180 days of marketing exclusivity for the product; - Par was granted tentative approvals for the company's ANDAs for ondansetron HCl
tablets in 4 mg, 8 mg, 16 mg and 24 mg strengths, and risperidone 1 mg/mL oral solution.
GlaxoSmithKline currently markets ondansetron HCl ODT under the brand name Zofran ODT(R).
Par expects ondansetron HCl ODT to be launched no later than December 2006.
Tablets are the generic version of GlaxoSmithKline's Zofran(R) Tablets, which had annual sales of approximately $600 million, based on IMS data, for the 12 month period ended June 30, 2005.