SPARC dips as FDA rejects Levetiracetam NDA
USFDA rejected NDA for Levetiracetam extended-release tablets 1000mg and 1500mg, an anti-epileptic product.
Sun Pharma Advanced Research Company (SPARC) is trading lower by 4% to Rs 124 after the company announced that the US Food and Drug Administration (FDA) rejected New Drug Application (NDA) for Levetiracetam extended-release tablets.
“The company announced the receipt of a Complete Response Letter from the USFDA on its NDA for Levetiracetam extended-release tablets, 1000mg and 1500mg, an anti-epileptic product. A complete response letter is a communication from the FDA to companies that an NDA cannot be approved in its present form,” SPARC said in a regulatory filing.
In the complete response letter, the FDA specified that the clinical data submitted by SPARC establishes bioequivalence in the fasted state. However, the FDA has raised certain queries on the pharmacokinetic data in the fed state. SPARC is evaluating the contents of the letter and plans further discussions with the FDA, it added.
The stock opened at Rs 125 and hit a low of Rs 121 on NSE. A combined 247,468 shares changed hands on the counter till 1252 hours on NSE and BSE.
“The company announced the receipt of a Complete Response Letter from the USFDA on its NDA for Levetiracetam extended-release tablets, 1000mg and 1500mg, an anti-epileptic product. A complete response letter is a communication from the FDA to companies that an NDA cannot be approved in its present form,” SPARC said in a regulatory filing.
In the complete response letter, the FDA specified that the clinical data submitted by SPARC establishes bioequivalence in the fasted state. However, the FDA has raised certain queries on the pharmacokinetic data in the fed state. SPARC is evaluating the contents of the letter and plans further discussions with the FDA, it added.
The stock opened at Rs 125 and hit a low of Rs 121 on NSE. A combined 247,468 shares changed hands on the counter till 1252 hours on NSE and BSE.