Itonis Inc (ITNS)

[Darth Vader II]

Wrong, homervb - FDA did not approve Emesyl - ITNS applied for and got a NDC number, which has nothing to do with FDA approval. Anyone can apply for and get a NDC number; others have posted about this issue before.

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm119742.htm

"FDA makes information available to the public about drug establishments and products through the NDC Directory. The NDC Directory is limited to prescription drugs and insulin products. The NDC, a unique ten-digit number, serves as a universal product identifier for human drugs in commercial distribution. FDA assigns the first five digits (known as the labeler code) and the registrant assigns the last 5-digits (known as the product and package code). Assignment of an NDC number does not denote approval of the product."