fda ods approved, page-17

I thought I would double check with some more searches and found more FDA granted Orphan Drug Designations in 2010.

A good one is the recently granted drug Epitalon from ASX listed company BioDiem (BDM) on 09 Sept 2010.
See announcement, http://www.asx.net.au/asx/statistics/displayAnnouncement.do?display=pdf&idsId=01096692


Another is Ciprofloxacin from Bayer in Feb 2010,
See link, http://www.pharma.bayer.com/scripts/pages/en/news_room/news_room/news_room88.php


One more is BMN-701 from BioMarin in Aug 2010,
See link, http://www.pharmpro.com/news/2010/08/agencies-and-organizations-BioMarin-Receives-Orphan-Drug-Designation/

When I searched for these drugs on the FDA website they all showed 'Not FDA Approved for Orphan Indication'.


Of particular notice is the paragraph from the second article for Ciprofloxacin from Bayer, it says -

About Orphan Drug Designation in the United States

Under legislation passed by the U.S. Congress in 1983, the Orphan Drugs Act provides incentives to sponsors to develop products for rare diseases. The first sponsor who obtains marketing approval for a designated orphan drug or biological product is granted US market exclusivity for a seven-year period. Exclusivity begins on the date that the marketing application is approved by the FDA for the designated orphan drug and applies only to the indication for which the drug has been designated and approved. The approval of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and efficacy of a compound must be established through adequate and well-controlled studies.

After completing this quick extra research on what 'Orphan Drug Designation - Designated' means on the FDA site, I'm pretty sure that Prima has got ODS for CVAC.

I could be wrong, so until we get something official from the Prima take these post as just my thoughts on the matter.

Again thanks Loosecash for find this out.