FDA Pharma Quarterly Review

Our staff has reviewed some of the most significant pharmaceutical review decisions by the FDA over the past quarter.  A number of interesting drugs are in the development pipeline for many companies, awaiting their fate from the FDA.


  • Genzyme receives FDA approval for a manufacturing plant for the production of Farazyme, a drug for the treatment Fabry disease.  Fabry disease is an enzyme-related lipid storage disease.
    Genzyme Gets Nod From FDA For Plant (FDA / Wall St. Journal)
    NINDS Fabry Disease (National Institute of Health)
  • The kidney cancer drug axitinib by Pfizer was approved for used in treatment of advanced kidney cancer as a second-line treatment
    Pfizer Kidney Drug Gains FDA Approval (FDA / Wall St. Journal)
  • Amlin Pharmaceutical's diabetes drug Bydureon was approved for once-weekly treatment for type-2 diabetes
    FDA Approves Amylin's Bydureon Diabetes Drug (FDA / Wall. St. Journal)
  • A new drug approval for basal-cell carcinoma,  Erivedge (vismodegib), developed by Roche and marketed by Genentech Inc. paves the way for a new class of cancer drugs.  The new class of drugs known as "hedgehog drugs" targets cell communication pathways.  The entire course of treatment for the drug would average around t $75,000 per patients
    New Type of Cancer Drug Gets Approval (FDA / Wall St. Journal)
  • Cystic Fibrosis drug Kalydeco by Vertex Pharmaceuticals was approved for first-line treatment of cystic fibrosis with a genetic mutation in the CFTR gene, affecting approximately 1200 people in the US.  Treatment with the drug is priced at $294,000 per year due to the small amount of patients and the high cost of development.
    FDA Approves Cystic Fibrosis Drug (FDA / Wall St. Journal)
  • Two new suppliers of cancer drugs were approved by the FDA addressing an issue with shortages in the market due to a plant shutdown.
    Cancer-Drug Suppliers Approved (FDA / Wall St. Journal)

Denials and Warnings

  • Dapagliflozin, an experimental diabetes drug as a part of a joint venture between AstraZeneca and Bristol-Myers Squibb was denied approval by the FDA
    Drug Setback for Bristol, Astra (FDA / Wall St Journal)
  • Infinity Pharmaceuticals stopped development of hedgehog drug for pancreatic cancer after disappointing results.
    New Type of Cancer Drug Gets Approval (FDA / Wall St. Journal)
  • The FDA issued a general warning on statins, requiring manufactures to add risks such as an increased risk of diabetes, high sugar levels, and memory loss.  The warning affects over a dozen different drugs in one of the most widely prescribed drug segments
    FDA Warns on Statin Drugs (FDA / Wall St. Journal)
  • Merck was issued an FDA warning letter for failure to submit safety information for a rodent study in its diabetes drug Januvia and is required to resubmit a final study design within 30 days.
    Merck Gets FDA Warning Letter on Drug Study (FDA / Wall St. Journal)
Did we miss something or do you have any suggestions?  Let us know in the comments!


  1. Adding general waning to statin drugs is not enough. It shouldn't be sold or prescribed by doctors. We all know how harmful it is. Please don't let people take this kind of drug.

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