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# Complete Response for Sun Elepsia XR
- URL: https://www.fdaweb.com/complete-response-for-sun-elepsia-xr/
- Published: 2017-05-25T12:00:00.000Z
- Updated: 2026-09-14T22:25:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138782

FDA has sent a complete response letter to Sun Pharma for its NDA for Elepsia XR (levetiracetam) extended-release tablets 1,000 mg and 1,500 mg. A company disclosure [letter](http://corporates.bseindia.com/xml-data/corpfiling/AttachLive/9512b84a-06a6-4ecb-8444-3bd0dca242c4.pdf?ref=fdaweb.com) to the National Stock Exchange of India says the FDA letter references the agency’s recent [inspection](https://www.fdaweb.com/fda-issues-lengthy-483-to-sun-pharmaceutical/) at the company’s Halol manufacturing site and says that deficiencies identified in the inspection must be satisfactorily resolved before the NDA can be approved.

The company says it is working with FDA to resolve current good manufacturing practice deviations at Halol and has taken several corrective measures.

Earlier this year FDA released an FDA-483 with 11 inspection [findings](https://www.fdaweb.com/fda-releases-sun-form-483-after-latest-inspection-in-india/) on the company’s Dadra facility.