FDA Approves Entresto

July 7, 2015 — The U.S. Food and Drug Administration today approved Entresto(sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure. Entresto Generic Name: sacubitril and valsartanDate of Approval: July 7, 2015Company: Novartis Pharmaceuticals...

Read More

FDA Approves Odomzo

Odomzo (sonidegib) Capsules Company: Novartis Pharmaceuticals CorporationDate of Approval: July 24, 2015Treatment for: Basal Cell Carcinoma Odomzo is the second hedgehog pathway inhibitor approved for the treatment of basal cell carcinoma. The U.S. Food and Drug Administration (FDA) has approved Odomzo (sonidegib), an oral hedgehog pathway inhibitor for the...

Read More

FDA Approves Daklinza

Daklinza (daclatasvir) Tablets Company: Bristol-Myers Squibb CompanyDate of Approval: July 24, 2015Treatment for: Chronic Hepatitis C Daklinza in combination with sofosbuvir is the first 12-week, once-daily, all-oral treatment regimen for patients with chronic hepatitis C virus (HCV) genotype 3. The U.S. Food and Drug Administration (FDA) has approved Daklinza...

Read More

New Drug Approval Process

FDA Approvals It takes on average 12 years and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans. Only one in 1000 of the compounds...

Read More

FDA Takes Action Against Unapproved Prescription Ear Drop Products

July 1, 2015 The U.S Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation. The unapproved prescription ear drops contain active ingredients such as benzocaine...

Read More

FDA approves brain implant to help reduce Parkinson’s disease and essential tremor symptoms

 U.S. Food and Drug Administration today approved the Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson’s disease and essential tremor, a movement disorder that is one of the most common causes of tremors. The Brio Neurostimulation System can help some patients when medication alone may not provide...

Read More