FDA seeks more data from Teva Pharm on Treanda
TEL AVIV Oct 23 (Reuters) - The U.S. Food and Drug Administration is seeking more data from Teva Pharmaceutical Industries regarding its request to expand the use of its chemotherapy drug Treanda for non-Hodgkin lymphoma.
Teva obtained Treanda through its acquisition of Cephalon last year and the drug generated $139 million in sales in the second quarter of 2012.
Teva is seeking to expand the use of Treanda as a first-line treatment of patients with indolent B cell non-Hodgkin lymphoma in combination with rituximab, an antibody used to treat non-Hodgkin lymphoma. The FDA requested additional data regarding progression free survival.
"Teva is currently evaluating all options to obtain the requested data," the company said in a statement on Tuesday.
Treanda is currently indicated as a secondary treatment for non-Hodgkin lymphoma. (Reporting by Tova Cohen)
- Hong Kong protesters plan march after fruitless talks with government
- NOAA employee charged with stealing U.S. dam information
- Sweden gets two new sightings, as hunt for undersea intruder goes on
- Special Report: Traffickers use abductions, prison ships to feed Asian slave trade
- Three Denver girls reportedly en route to Turkey detained, sent home