Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA issued a complete response letter for the firm's supplemental new drug application for Xarelto (rivaroxaban) for the reduction of the risk of secondary cardiovascular events in patients with acute coronary syndrome

Janssen Research and Development LLC, a unit of Johnson & Johnson, of New Brunswick, N.J., submitted a supplemental new drug application to the FDA for Zytiga (abiraterone acetate) to extend its use with prednisone in metastatic castration-resistant prostate cancer for patients who are asymptomatic or mildly symptomatic after androgen deprivation therapy failure and before chemotherapy

Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said it submitted a new drug application seeking approval of canagliflozin, an oral, once-daily selective sodium glucose co-transporter 2 inhibitor, for treating adults with Type II diabetes

Janssen Therapeutics, of Titusville, N.J., a unit of Johnson & Johnson, said the FDA approved Intelence (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI), for use in combination with other antiretroviral (ARV) medications in HIV-1 treatment-experienced pediatric patients, ages 6 to younger than 18, who are experiencing virologic failure with HIV-1 strains resistant to NNRTIs and other ARVs

Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA assigned a priority review designation for the supplemental new drug application for Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome