Astellas Pharma US, Inc.: IZERVAY

Federal Food, Drug, and Cosmetic Act for IZERVAY (avacincaptad pegol intravitreal solution).

This "Prior Approval" supplement with clinical data to your application proposes a new, expanded dosing regimen (beyond 12 months) for the approved indication of treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

However, per the pre-specified testing procedure, formal statistical inferential conclusion could only be made for the comparison of EM versus Sham.

Izervay (avacincaptad pegol ophthalmic solution) 20 mg/mL solution with an extended dosing regimen should be submitted to support your proposed labeling revisions.

Following the pre-license inspection of a listed in this application, FDA conveyed deficiencies to the facility's representative.

FDA has reviewed the facility's responses to the referenced deficiencies, and all deficiencies have not been satisfactorily resolved.

Satisfactory responses to these deficiencies should be provided to the inspection team prior to submitting your complete response.

Your complete response should include the date of the facility's response to the FDA Form 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.

Cosmetic Act for solifenacin succinate oral suspension, | mg/mL.

3. The drug product specification and post-approval stability program do not include the test methods and acceptance criteria to demonstrate that the product is free, and remains free, of the objectionable microorganisms in the ma.

Such an action will be taken if the pediatric formulation for this drug is not marketed within one year of our public notification granting exclusivity on August 10, 2017.

Submit draft carton and container labeling based on our proposed revisions dated May 3, 2017, and May 24, 2017.