Cipla USA, Inc.

NDA 210168 COMPLETE RESPONSE

Cipla USA, Inc.

Attention: Michele Crawley

U.S. Agent for Cipla Limited, India 10 Independence Boulevard

Suite 300

Warren, NJ 07059

Dear Ms. Crawley:

Please refer to your new drug a

We acknowledge receipt of your amendment dated , which constituted a complete response to our , action letter.

We have completed our review of this application, as amended, and have determined that we cannot approve this application in its present form. We have described our

reasons for this action below and, where possible, our recommendations to address these issues.

FACILITY INSPECTIONS

During a recent surveillance inspection of the) a manufacturing facility for this application, our field investigator conveyed iciencies to the representative of the facility. Satisfactory resolution of these

deficiencies is required before this application may be approved.

ADDITIONAL COMMENTS

Reference ID: 5351466

NDA 210168 Page 2

OTHER

Within one year after the date of this letter, you are required to resubmit or take other actions available under 21 CFR 314.110. If you do not take one of these actions, we may consider your lack of response a request to withdraw the application under

21 CFR 314.65. You may also request an extension of time in which to resubmit the application.

A resubmission must fully address all the deficiencies listed in this letter and should be clearly marked with "RESUBMISSION" in large font, bolded type at the beginning of the cover letter of the submission. The cover letter should clearly state that you consider this resubmission a complete response to the deficiencies outlined in this letter. A partial response to this letter will not be processed as a resubmission and will not start a new review cycle.

You may request a meeting or teleconference with us to discuss what steps you need to take before the application may be approved. If you wish to have such a meeting, submit your meeting request as described in the draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.

If you have any questions, please call oe

Sincerely,

{See appended electronic signature page} (b) (4)

U.S. Food and Drug Administration Silver Spring, MD 20993 www.fda.gov

Reference ID: 5351466

Signature Page 1 of 1

This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.

(b) (4)

03/22/2024 11:33:23 AM

Reference ID: 5351466