Mylan Pharmaceuticals Inc., a Viatris Company: NDA 204311

We also acknowledge receipt of your amendment dated July 15, 2022, which constituted a complete response to our August 6, 2019, complete response letter.

Company (FEI # 30002785310, Vizianagaram, Andhra Pradesh, India) manufacturing facility listed in this application, FDA conveyed deficiencies to the representatives of the facility.

Therefore, in your future submissions to this application, including any resubmission, please update your Form FDA 356h (Field 20), cover letter, and annotated labeling to omit identification of ™® as a basis for approval of your application.

The drug product is not eligible for procurement under the President's Emergency Plan or AIDS Relief (PEPFAR) program unless and until you have been notified in writing hat, based on your resubmission, the application is tentatively approved.