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, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for Elepsia XR (levetiracetam) extended-release tablets, 1000 mg and 1500 mg.

We acknowledge receipt of your amendment dated September 23, 2016, which constituted a complete response to our September 23, 2015, action letter. Specifically, this amendment included (1) information to address Agency comments regarding facility deficiencies, and (2) revised draft labeling, with proposed changes to dosing information for patients with renal impairment and additional labeling modifications to align with Keppra XR (innovator) labeling approved April 6, 2016.

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

The deficiencies associated with your manufacturing facilities remain unresolved. Specifically, 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 are unable to include in ELEPSIA XR labeling dosing information | skal oe)

Reference ID: 4073337

NDA 204417 Page 2

We reserve further comment on the proposed labeling until the application is otherwise adequate. We encourage you to review the labeling review resources on the PLR Requirements for Prescribing Information and Pregnancy and Lactation Labeling Final Rule websites, including regulations and related guidance documents and the Selected Requirements for Prescribing Information (SRPI) — a checklist of important format items from labeling regulations and guidances.

If you revise labeling, use the SRPI checklist to ensure that the prescribing information conforms to format items in regulations and guidances. Your response must include updated content of labeling [21 CFR 314.50(1)(1)(i)] in structured product labeling (SPL) format as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.

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. 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 draft FDA Guidance for Industry, “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products,” March 2015 at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm 43743 L.pdf.

If you have any questions, please contact LaShawn Dianat, PharmD, Regulatory Project Manager, by phone at (240) 402-7713 or by email at lashawn.dianat@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: 4073337

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 03/22/2017

Reference ID: 4073337