FDA rejects Watson prostate cancer drug
MORRISTOWN, N.J. The Food and Drug Administration has rejected an application from Watson Pharmaceuticals for a new formulation of a prostate cancer drug.
Watson announced Tuesday that the FDA had given it a complete response letter for its approval application for a 24-week formulation of Trelstar (triptorelin pamoate for injectable suspension) in the 22.5-mg strength. Watson had prepared the application with Swiss biotech company Debiopharm Group.
The FDA asked Watson for additional clinical testing data, third-party manufacturing data and data related to chemistry, manufacturing and controls. Watson said it was working to provide the agency with the information requested.
Sandoz launches a generic version of Vantin
PRINCETON, N.J. Generic drug maker Sandoz has launched a version of an oral antibiotic.
The company, a division of Swiss drug maker Novartis, announced the launch of cefpodoxime proxetil oral suspension in the 50 mg per 5 mL and 100 mg per 5 mL strengths, used to treat such mild to moderate infections caused by Gram positive and Gram negative bacteria as ear infections, sore throats and sinusitis.
The drug is a generic version of Pfizer’s Vantin. Branded and generic formulations of cefpodoxime proxetil oral suspension were about $4 million in the 12 months ended in April, according to IMS Health data.
OSI Pharmaceuticals, Genentech announce results of Tarceva trial
MELVILLE, N.Y. A drug used to treat non-small cell lung cancer and pancreatic cancers extended the survival of patients with advanced NSCLC taking it immediately after chemotherapy, according to results of a late-stage clinical study.
OSI Pharmaceuticals and Genentech announced the results of a phase 3 trial of Tarceva (erlotinib), which they will present at the 13th World Congress on Lung Cancer, on Aug. 4 in San Francisco.
“This study has now not only confirmed that immediate treatment of Tarceva after initial chemotherapy delayed the progression of disease, but also importantly helped patients in the study live longer,” principal investigator Federico Cappuzzo of the Instituto Clinico Humanitas IRCCS in Milan, Italy, said. “This is good news for doctors and their patients, since advanced lung cancer is one of the most challenging cancers to treat and is often associated with a very short life expectancy.”