Drug Shortages: Has the FDA Response Made an Impact?

Rationing of much needed medications for patients is a scary thought for me as a healthcare professional. I can understand when an orphan drug may go in short supply for a rare disease, but when commonly used medications like antibiotics and intravenous fluids become scarce, I wonder what the forces are that cause this to happen, and why can’t it be prevented? Worse yet,...

Read More

FDA Approves Addyi

Addyi (flibanserin) Tablets Company: Sprout Pharmaceuticals, Inc.Date of Approval: August 18, 2015Treatment for: Hypoactive Sexual Desire Disorder Addyi is the first and only FDA-approved treatment for hypoactive sexual desire disorder, the most common form of female sexual dysfunction.The U.S. FDA has approved Addyi (flibanserin), a once-daily, non-hormonal, multifunctional...

Read More

FDA Approves Repatha

FDA approved: Yes (First approved August 27th, 2015) Brand name: Repatha Generic name: evolocumab Company: Amgen Inc. Treatment for: High Cholesterol, Familial Heterozygous, High Cholesterol, Familial Homozygous,High Cholesterol Repatha (evolocumab) is a monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) for the...

Read More

FDA Approves Aristada

Aristada Generic Name: aripiprazole lauroxilDate of Approval: October 5, 2015Company: Alkermes, Inc. Aristada is the first atypical antipsychotic with once-monthly and six-weekly dosing options. The U.S. Food and Drug Administration (FDA) has approved Aristada (aripiprazole lauroxil), an extended-release injectable atypical antipsychotic for the treatment of patients...

Read More

Cost to Develop and Win Marketing Approval for a New Drug Is $2.6 Billion

Developing a new prescription medicine that gains marketing approval, a process often lasting longer than a decade, is estimated to cost $2,558 million, according to a new study by the Tufts Center for the Study of Drug Development. The $2,558 million figure per approved compound is based on estimated: Average out-of-pocket cost of $1,395 million Time costs (expected...

Read More