Lupin gets US FDA nod for Divalprox
Pharmaceutical firm Lupin today said it has received final approval from US Food and Drug Administrator for Divalprox Sodium Delayed Release tablets, used to control seizures in the treatment of epilepsy.
By PTI |
MUMBAI: Pharmaceutical firm Lupin today said it has received final approval from US Food and Drug Administrator for Divalprox Sodium Delayed Release tablets, used to control seizures in the treatment of epilepsy.
Lupin Pharmaceuticals Inc has received final approval for the company's abbreviated new drug application for Divalprox Sodium Delayed Release tablets in the strength of 125 mg, 250 mg and 500 mg, Lupin said in a filing to the Bombay Stock Exchange.
Lupin's Divalprox Sodium Delayed Release tablets are the generic equivalent of Abbott Laboratories' Depakote tablets that had annual sales of around 803 million dollars for the 12 months ended March 2008.
With this approval, the cumulative Abbreviated New Drug Application (ANDA) approvals of the company stand at 31 (including three tentative approvals) and 34 pending approvals from the USFDA.
Shares of Lupin were trading at Rs 736.10, up 0.29 per cent on the BSE in afternoon trade.
Lupin Pharmaceuticals Inc has received final approval for the company's abbreviated new drug application for Divalprox Sodium Delayed Release tablets in the strength of 125 mg, 250 mg and 500 mg, Lupin said in a filing to the Bombay Stock Exchange.
Lupin's Divalprox Sodium Delayed Release tablets are the generic equivalent of Abbott Laboratories' Depakote tablets that had annual sales of around 803 million dollars for the 12 months ended March 2008.
With this approval, the cumulative Abbreviated New Drug Application (ANDA) approvals of the company stand at 31 (including three tentative approvals) and 34 pending approvals from the USFDA.
Shares of Lupin were trading at Rs 736.10, up 0.29 per cent on the BSE in afternoon trade.
Start a SIP with as low as ₹500 with ET Money App!
Download
The Economic Times News App for Quarterly Results, Latest News in ITR, Business, Share Market, Live Sensex News & More.
The Economic Times News App for Quarterly Results, Latest News in ITR, Business, Share Market, Live Sensex News & More.
ADVERTISEMENT
