Citizen Petition FDA-2016-P-0713 was denied yesterday. Just reviewed the docket.

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anonymous said:
What actually does this petition mean? Anyone.
Click to expand...
ANDA is an abbreviated new drug application (generic), 505b2 is a branded drug that uses an existing product as a reference - fewer clinical trials. Pernix asked the FDA to prevent any generic or branded drug that cites zohydro as a reference drug from being accepted by the FDA. Pernix argued that the patent on the drug protects the IP surrounding bead tech and this information is critical to safety labeling. Basically they argued that their IP is critical for safety (which would be required if any generic were to apply for marketing approval) was not on the label for zohydro and therefore no other company can make a generic until the patent expires.

The FDA basically said Pernix did the clinical trials that can be referenced in a 505b2 application and therefore Pernix was denied additional market exclusivity.

This really doesn't do anything other than allow someone else to develop a similar drug when normal exclusivity ends
 






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