Sun Pharma Advanced Research Company Limited: Elepsia XR

Cosmetic Act for Elepsia XR (levetiracetam) extended-release tablets, 1000 mg and 1500 mg.

We are unable to include in ELEPSIA XR labeling dosing information | skal oe)

We reserve further comment on the proposed labeling until the application is otherwise adequate.

Between the FDA and Sponsors or Applicants of PDUFA Products," March 2015 at http://www.

Act), for Elepsia XR (levetiracetam) extended-release tablets, 1000 mg and 1500 mg.

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.

We note that, on June 19, 2015, you submitted a prior approval (PA) labeling supplement (S001) 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Given that the approval of this original NDA has been rescinded, we consider your pending supplement to be a minor labeling amendment to the original, now pending, NDA.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.

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 April 9, 2015, submission constituted a complete response to our November 24, 2014, action letter.

1. Please submit the labeling attached to this correspondence, which contains minor revisions based on the labeling submitted April 9, 2015. Pleas so re-submit the carton and container labels in the April 9, 2015, submission, as these labels are acceptable.

Sun Pharma Advanced Research Company Limited c/o Ora, Inc.

Xelpros (latanoprost ophthalmic emulsion) 0.005%.

This can be accomplished by submission of an "Erratum" page with a statement that throughout the NDA the product name was corrected from "latanoprost ophthalmic © to "latanoprost ophthalmic emulsion."

4. On July 9, 2014, you submitted draft carton and container labels for all three presentations containing the words " © » Please submit revised labels for all presentations where these words are replaced with "For Topical Use in the Eye."