Dec 17, 2013, 09.55 PM IST
The US Food and Drug Administration (USFDA) has sent a letter seeking additional studies related to the efficacy and safety of its Venlafaxine extended-release 300 mg tablets, Sun Pharma Advanced Research Company (SPARC) said in a statement.
Tags Sun Pharma, New Drug Application (NDA), US health regulator , Sun Pharma Advanced Research Company (SPARC)
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USFDA disapproves Sun Pharma unit's product in present form
The US Food and Drug Administration (USFDA) has sent a letter seeking additional studies related to the efficacy and safety of its Venlafaxine extended-release 300 mg tablets, Sun Pharma Advanced Research Company (SPARC) said in a statement.
Like this story, share it with millions of investors on M3
USFDA disapproves Sun Pharma unit's product in present form
The US Food and Drug Administration (USFDA) has sent a letter seeking additional studies related to the efficacy and safety of its Venlafaxine extended-release 300 mg tablets, Sun Pharma Advanced Research Company (SPARC) said in a statement.
The US Food and Drug Administration (USFDA) has sent a letter seeking additional studies related to the efficacy and safety of its Venlafaxine extended-release 300 mg tablets, Sun Pharma Advanced Research Company (SPARC) said in a statement.
Also read: US FDA approvals to help boost Cipla, Ranbaxy
SPARC said it is in receipt of a Complete Response Letter, a communication from the USFDA that a new drug application cannot be approved in its present form. \\\\"Based on the FDA's feedback, SPARC is evaluating the commercial viability of this product,\\\\" it added.
SPARC was demerged from Sun Pharmaceutical Industries Ltd. As a research and drug discovery company in 2007. Shares of SPARC rose 0.15 per cent to Rs 163.80 at the close on the BSE.
Sun Pharma stock price
On December 18, 2013, at 11:14 hrs Sun Pharmaceutical Industries was quoting at Rs 573.05, up Rs 4.05, or 0.71 percent. The 52-week high of the share was Rs 650.00 and the 52-week low was Rs 347.10.
The company's trailing 12-month (TTM) EPS was at Rs 0.89 per share as per the quarter ended September 2013. The stock's price-to-earnings (P/E) ratio was 643.88. The latest book value of the company is Rs 41.64 per share. At current value, the price-to-book value of the company is 13.76.
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