CENTER FOR DRUG EVALUATION AND
RESEARCH

APPLICATION NUMBER:

205718Orig1s000
ENVIRONMENTAL ASSESSMENT

 Helsinn Healthcare SA submitted a claim of categorical exclusion from the requirement
to prepare an environmental assessment (EA) for AKYNZEO. AKYNZEO is a ?xed
dose combination of netupitant, a substance P/neurokinin 1 receptor antagonist,
and palonosetron, a serotonin subtype 3 receptor antagonist.

I have reviewed the claim and determined that the application quali?es-for a categorical

exclusion under 21 CFR 2531 No extraordinary circumstances are indicated. No
further action is required.

Raanan A. Bloom, 

Staff

Reference ID: 3596493

 

This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.

 

Isl

 

RAANAN A BLOOM
07/21/2014

Reference ID: 3596493