Bausch + Lomb announced the U.S. FDA accepted the New Drug Application for the company’s sub-micron loteprednol etabonate ophthalmic gel 0.38% with a PDUFA date of Feb. 25, 2019.
The U.S. FDA approved Senseonics Holdings’ Premarket Approval application to market the company’s Eversense Continuous Glucose Monitoring System to people with diabetes.
The FDA approved a supplemental NDA that expands the use of Sunovion’s Latuda to include treating major depressive episode associated with bipolar I disorder in pediatric patients.
Synergy Pharmaceuticals Inc. announced that the U.S. FDA approved Trulance (plecanatide) 3-mg tablet for the once-daily treatment of irritable bowel syndrome with constipation in adults.
AstraZeneca and Merck announced that the Japanese Ministry of Health, Labour and Welfare approved Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer, regardless of their BRCA mutation status, who responded to their last platinum-based chemotherapy.
Trisenox (arsenic trioxide) injection was approved in combination with tretinoin for treating adults with newly diagnosed low-risk acute promyelocytic leukemia.
Alexion Pharmaceuticals Inc. announced that the MHLW in Japan approved Soliris (eculizumab) as a treatment for patients with generalized myasthenia gravis.
Genentech announced that the U.S. FDA approved Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence.
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration approved Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
Sunovion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration approved the New Drug Application for Lonhala Magnair (glycopyrrolate) Inhalation Solution (25 mcg twice daily) – also known as SUN-101/eFlow – for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema.
