SEBI Reg. Investment Advisor

Download App

MoneyWorks4Me

SPARC receives negative response from USFDA on Levetiracetam NDA

06 May 2013 Evaluate

Sun Pharma Advanced Research Company (SPARC) has received a complete response letter from the US Food and Drug Administration (USFDA) on its New Drug Application (NDA) for Levetiracetam Extended-release tablets, 1000mg and 1500mg, an anti-epileptic product. A complete response letter is a communication from the USFDA to companies that an NDA cannot be approved in its present form.

In the complete response letter, the USFDA specified that the clinical data submitted by SPARC establishes bioequivalence in the fasted state. However, the USFDA has raised certain queries on the Pharmacokinetic data in the fed state. The company is evaluating the contents of the letter and is planning for further discussions with the USFDA.

SPARC is an international pharmaceutical company engaged in research and development of drugs and delivery systems.

Sun Pharma Adv. Res Share Price

147.90 -4.25 (-2.79%)
17-Apr-2026 16:59 View Price Chart
Peers
Company Name CMP
Syngene Internation. 435.70
Indegene 486.80
CMS Info Systems 318.00
JITF Infralogistics 338.00
Sagility 42.95
View more..

About MoneyWorks4Me

MoneyWorks4Me is a SEBI-registered Investment Adviser (IA) dedicated to helping investors build long-term wealth through transparent, research-driven, conflict-free guidance. Founded in 2008, we started our journey as a Research Analyst (RA), providing deep fundamental analysis, intrinsic value insights, and long-term investing frameworks for Indian equities. In 2017, we transitioned to a full-fledged SEBI-registered Investment Adviser, strengthening our commitment to acting as a fiduciary—always putting the investor’s interest first.

Our Vision

To become India’s most trusted, research-powered fiduciary advisory platform—where every investor, regardless of experience, can make calm, confident, and well-reasoned investment decisions.

What Makes MoneyWorks4Me Different

Our Approach: Ensuring compounding work its magic on client portfolio.

MoneyWorks4Me ensures this through:

×