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,...

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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...

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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...

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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...

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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...

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FDA Approves Onivyde

October 22, 2015 — 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. According to the National Cancer Institute, there will be 48,960 new cases...

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