Boehringer Ingelheim announced Tuesday the US Food and Drug Administration (FDA) approved once-daily Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray to treat airflow obstruction in patients suffering from chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
The FDA says the investigational drug combination of daclatasvir (Daklinza/ Bristol-Myers Squibb) and sofosbuvir (Sovaldi/Gilead ) may now be given to patients who have hepatitis C infections with either advanced cirrhosis or infections that have come back after patients received a liver transplant.
The US Food and Drug Administration today approved 3-month paliperidone palmitate (Invega Trinza/Janssen) a longer-lasting version of Janssen’s paliperidone palmitate product marketed as Invega Sustenna, a treatment that works for only 1 month per injection.
FDA approves device to help kidney failure patients with dialysis-related-amyloidosis. Known as the Lixelle Beta-2 microglobulin Apheresis Column, the device is already in use in Japan, where it is manufactured.
Manufacturers of prescription testosterone products must change their drug labels to include a warning about increased risk of heart attacks and strokes. The labeling change, announced today by the US Food and Drug Administration (FDA) addresses the use of testosterone by men whose decreased level of the hormone is due to aging.