• Antares Pharma Inc., of Ewing, N.J., reported FDA approval of Otrexup (methotrexate) injection, a version of methotrexate for once weekly self-administration with a single dose, disposable auto injector. Otrexup is indicated for adults with severe active rheumatoid arthritis (RA) who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first-line therapy including full-dose non-steroidal anti-inflammatory agents, or children with active polyarticular juvenile idiopathic arthritis. The FDA also approved adult use of Otrexup for symptomatic control of severe recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy.

• Boehringer Ingelheim GmbH, of Ingelheim, Germany, said it submitted a marketing authorization application to the European Medicines Agency for oral triple angiokinase inhibitor nintedanib in combination with docetaxel for the treatment of patients with locally advanced, metastatic or recurrent non-small-cell lung cancer of adenocarcinoma tumor histology after first-line chemotherapy. The application included data from the Phase III LUME-Lung 1 trial, which showed a survival benefit when nintedanib was given as an add-on treatment in a broad second-line adenocarcinoma patient population vs. an active comparator.

• The FDA granted approval to Teva Pharmaceutical Industries Ltd., of Jerusalem, for a generic equivalent of Tobi (tobramycin inhalation solution, Novartis AG). Teva plans to launch the product in late November. Tobi is marketed for management of people with cystic fibrosis whose lungs contain Pseudomonas aeruginosa.