Sun Pharma Advanced Research Company LimitedElepsia XR (levetiracetam) extended-release tablets, 1000 mg and 1500 mg

NDA 204417 COMPLETE RESPONSE

Sun Pharma Advanced Research Company Limited c/o Salamandra, LLC

Attention: Karin A. Kook, PhD, Managing Director One Bethesda Center, 4800 Hampden Lane, Ste. 900 Bethesda, Maryland 20814

Dear Dr. Kook:

Please refer to your New Drug Application (NDA), dated May 24, 2012, received May 29, 2012, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), for Elepsia XR (levetiracetam) extended-release tablets, 1000 mg and 1500 mg.

We also refer to our September 23, 2015, letter informing you that we have rescinded our March 2, 2015, approval of NDA 204417.

We have completed our review of this application, as submitted, 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 recent inspections of the Sun Pharmaceutical Industries, Limited (Sun Pharma) (FEI # 3002809586), facilities for this application, our field investigator conveyed deficiencies to the representative of the facilities. Satisfactory resolution of these deficiencies is required before this application may be approved.

PRESCRIBING INFORMATION

We note that, on June 19, 2015, you submitted a prior approval (PA) labeling supplement (S- 001) to this NDA, which proposes changes to Table | in the Dosage and Administration section of labeling. Given that the approval of this original NDA has been rescinded, we consider your pending supplement to be a minor labeling amendment to the original, now pending, NDA.

As such, we ask that, when you respond to this letter, you submit revised draft labeling that includes your proposed changes described in your June 19, 2015, submission.

In addition, submit updated content of labeling [21 CFR 314.50(1)(1)() in structured product labeling (SPL) format as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.

Reference ID: 3824030

NDA 204417 Page 2

To facilitate review of your submission, using the March 2, 2015, agreed upon labeling as the base document, please provide a highlighted or marked-up copy of labeling that shows all changes, as well as a clean Word version. The marked-up copy should include annotations that support any proposed changes.

REGULATORY INFORMATION

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. 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 FDA Guidance for Industry, “Formal Meetings Between the FDA and Sponsors or Applicants,” May 2009 at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM153222.pdf.

If you have any questions, please contact Jacqueline H. Ware, PharmD, Supervisory Regulatory Project Manager, by phone at (301) 796-1160 or by email at Jacqueline. ware@fda.hhs.gov.

Sincerely, {See appended electronic signature page}

Billy Dunn, MD

Director

Division of Neurology Products

Office of Drug Evaluation I

Center for Drug Evaluation and Research

Reference ID: 3824030

This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature.

WILLIAM H Dunn 09/23/2015

Reference ID: 3824030