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Showing posts with label Orphan drugs. Show all posts
Showing posts with label Orphan drugs. Show all posts
Monday, February 18, 2013
Sunday, January 27, 2013
Commentary You have free access to this content Do we need authorized orphan drugs when compounded medications are available?
Summary
What is known and Objective: Orphan drugs are used to diagnose, prevent or treat a rare disease. This Commentary aims to present a number of case studies questioning the need for designating compounded medications with a long history of effective use, which is well-supported by published clinical evidence.
Comment: Prior to the market introduction of orphan drugs, medication compounding was done in our hospital pharmacy for several rare diseases. Examples include amifampridine for the treatment of Lambert–Eaton myasthenic syndrome (Firdapse®), ibuprofen for the treatment of neonatal patent ductus arteriosus (Pedea®) and zinc acetate for the treatment of Wilson’s disease (Wilzin®). Several ‘non-orphan’ pharmaceutical products, used off-label for the treatment of rare diseases, that became orphan medicinal products include Hydrea® for the treatment of sickle-cell syndrome (Siklos®) and Viagra® for the treatment of pulmonary arterial hypertension (Revatio®).
What is new and Conclusion: In our opinion, as indicated by our examples, a better balance should be struck between the development of orphan drugs along the recently established regulatory pathways and the pragmatic use of pharmacy-compounded products and evidence-based off-label use of already available commercial products. Societal needs would be best met by focusing orphan drug development on rare diseases for which there is a high unmet medical need.
Saturday, December 22, 2012
K-V Pharmaceutical And Orphan Drug Makena: Legal Update (12/22/12) ITC Won't Investigate Complaint
Orphan Druganaut Blog has a summary of the events in the trade complaint that K-V Pharmaceutical filed in October 2012 with the US International Trade
Commission (ITC). The complaint was an attempt to stop compounding pharmacies
from importing 17a hydroxyprogesterone caproate (“HPC”) to unlawfully
manufacture copies of orphan drug Makena. The US ITC that it will not
investigate the complaint.ad
Read Orphan Druganaut Blog here
Read Orphan Druganaut Blog here
Monday, October 1, 2012
Another FDA lawsuit over Exclusivity
FDA Law blog is reporting that there is another Orphan Drug Battle in that Depomed has Sued the FDA Over GRALISE Orphan Drug Exclusivity. The complaint and post can be read here.
Monday, September 24, 2012
The Makena Story
Michelle Oxman has written a blog entry entitled, What Does the Makena Story Tell Us About the Orphan Drug Act?, (September 24, 2012). The article deals with why prescription drugs are a large portion of health care spending. The article does a good job of explain the Orphan Drug Act (ODA) (P.L. 97-414) and of discussing the K-V v. FDA decision. To read this article click here.
Wednesday, September 19, 2012
New Article: Do we need authorized orphan drugs when compounded medications are available?
M. Dooms, Hilde Pince and Steven Simoens have written a Commentary for the Journal of Clinical Pharmacy and Therapeutics. The commentary is entitled, Do we need authorized orphan drugs when compounded medications are available? It appears in the September 14, 2012 edition and can be viewed here
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