NeuroDerm, Ltd.: carbidopa levodopa

(1) Based on results from the relative bioavailability study, ND0612-115, an adequate scientific bridge to levodopa based on pharmacokinetic (PK) exposure was established; however, an adequate scientific bridge was not established for the carbidopa PK exposure between Engolce and the reliedupon listed drug, Sinemet, at the highest proposed dosage regimen of Engolce.

We note that per the proposed labeling, patients may take other carbidopa/levodopa products in addition to Engolce.

, listed in the application, FDA conveyed deficiencies to the representative of the facility.

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the form FDA-483 prior to your complete response to your application.

Your complete responses should include the date(s) of the facility's response to the form FDA-483. The assessment of application approvability and the resolution of inspection deficiencies would be evaluated upon receipt of the complete response and may include re-inspection of the facility.

The facility should provide satisfactory responses to these deficiencies prior to your complete response to your application.

Your complete responses should outline the corrections taken in response to the inspection.

3. The comments in this section are not intended to convey human factors (HF)