USFDA

The U.S. Food and Drug Administration today approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.

Edwards Lifesciences Corporation, a global leader in the science of heart valves and hemodynamic monitoring, has received US Food and Drug Administration (FDA) approval for aortic valve-in-valve procedures using the Edwards Sapien XT transcatheter heart valve.

Stryker Corporation, one of the world's leading medical technology companies instruments division of interventional spine business unit has received clearance from the US Food and Drug Administration (FDA) to market its expanded indications of VertaPlex HV for the treatment of sacral insufficiency fractures.

The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.

Hyderabad-based Aurobindo Pharma received the final approval from the US Food and Drug Administration to manufacture and market generic Aripiprazole tablets used for treatment of psychotic conditions in the American market. The approval is for the tablets in the strengths of 2mg, 5mg, 10mg, 15mg, 20mg and 30mg.

The U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR mutation or ALK translocation should have disease progression on appropriate targeted therapy prior to receiving Opdivo. In a Phase 3 trial, CheckMate -057, Opdivo demonstrated superior overall survival (OS) in previously treated metastatic non-squamous NSCLC compared to chemotherapy, with a 27% reduction in the risk of death (hazard ratio: 0.73 [95% CI: 0.60, 0.89; p=0.0015]), based on a prespecified interim analysis.1 The median OS was 12.2 months in the Opdivo arm (95% CI: 9.7, 15.0) and 9.4 months in the docetaxel arm (95% CI: 8.0, 10.7). This approval expands Opdivo’s indication for previously treated metastatic squamous NSCLC to include the non-squamous patient population. Squamous and non-squamous NSCLC together represent approximately 85% to 90% of lung cancer cases.

The US Food and Drug Administration approved Alkermes Inc's Aristada (aripiprazole lauroxil) extended release injection to treat adults with schizophrenia.  Schizophrenia is a chronic, severe and disabling brain disorder affecting about one percent of Americans. Typically, symptoms are first seen in adults younger than 30 years of age. Aristada is administered by a health care professional every four to six weeks using an injection in the arm or buttocks.

Impax Laboratories, Inc., a specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved its generic version of glyburide tablets 1.25 mg, 2.5 mg, and 5 mg. The company is preparing for commercialisation of this product through Impax's generic division.

Allergan plc,, a leading global pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to market Juvederm Ultra XC for injection into the lips and perioral area for lip augmentation in adults over the age of 21.