Laboratorios Farmacéuticos ROVI, S.A.: Risvan

Your application referenced the Drug Master File (DMF) This DMF was found inadequate to support your submission and a deficiency letter was sent to the DMF holder on July 15, 2022. These deficiencies must be adequately addressed before this application can be approved.

The referenced DMF for sterile drug substance risperidone has been reviewed and determined to be inadequate.

Additionally, the maximum dose for the first batch of 2020 "revalidation" with the treatment No. 20T01769T, ™® exceeds the maximum dose of ©® Provide a summary of investigations, the root cause identified, potential impact on routine production, and corrective and preventative actions.

'ed September 10, 2021, although your IFU states:

Drug, and Cosmetic Act for risperidone extended-release injectable suspension.

On August 21, 2021, we sent an information request with several questions about your ophthalmologic examination data.

October 15, 2021. Of the six ophthalmologic questions in our August 21, 2021, information request, you must fully address questions 1, 2, 4, 5, and 6 in (or prior to) your NDA resubmission.

The results of your human factors (HF) validation study indicated the need for further revisions to your user interface in order to mitigate residual risk.

In particular, we are concerned that your intended users may have difficulty injecting the full dose of medication due to the viscosity of the product, as evidenced by use difficulties and use errors in your human factors validation study.

Any product redesign will require an additional human factors validation study to demonstrate that the design mitigations were effective.

2. In aresponse to an information request dated July 30, 2021, you provided additional information supporting the omission of 08 and © testing on the drug product.

However, no data for the drug product was included, specifically during long-term storage controlled room temperature).

Provide data demonstrating that © remains unchanged on stability of the drug product (e.g., result from drug product registration stability batches stored for 12 months under long-term conditions).

PLGA) to ensure short term freeze/thaw conditions do not adversely impact the drug product.

PBBM, etc. For an established safe space, the acceptable dissolution specifications should ensure bioequivalence/clinical relevance of future batches with dissolution profiles falling between the identified extreme ranges within the limits.

May 11, 2021. These deficiencies must be adequately addressed before this application can be approved.

Powder prefilled _syringe (Risperidone+PLGA)

1. We acknowledge the provided container closure integrity validation reports for the drug product and the diluent DMSO (UDMI-IVP-21-013/00 and UDMI-IVP-21014/00) by microbial immersion method in 1.11.1 (Seq-0023).

Satisfactory resolution of these deficiencies is required before this application may be approved.

Complete Response Letter while the travel restrictions remain in effect.

However, even if these deficiencies are addressed, the application cannot be approved until the required FDA inspections are completed and any findings are assessed with regard to our application.