Cadila Health up 3%, diabetic drug gets tentative USFDA nod

Written By Unknown on Selasa, 16 September 2014 | 16.03

"Zydus Cadila has received tentative approval from the US Food and Drug Administration (US FDA) to market (anti-diabetic drug) Glipizide extended release tablets in the strength of 2.5 mg, 5 mg and 10 mg," said the company in its filing.

Moneycontrol Bureau

Shares of  Cadila Healthcare rallied as much as 2.8 percent intraday Tuesday on getting tentative USFDA approval for anti-diabetic drug.

"Zydus Cadila has received tentative approval from the US Food and Drug Administration (US FDA) to market (anti-diabetic drug) Glipizide extended release tablets in the strength of 2.5 mg, 5 mg and 10 mg," said the company in its filing.

The estimated sales in 2014 for Glipizide extended release tablets is USD 90.1 million, as per IMS.

The group now has 97 approvals and has so far filed 249 ANDAs since 2003-04, it added.

Meanwhile, Zydus and Gilead on Monday signed a non-exclusive licensing agreement to manufacture breakthrough treatment for Hepatitis C.

The agreement will allow the company to manufacture sofosbuvir (approved under the trade name Sovaldi by USFDA in December 2013 and by the European Commission in January 2014) and the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 90 developing countries.

At 13:13 hours IST, the stock was quoting at Rs 1,292.40, up Rs 7.40, or 0.58 percent on the BSE.

Posted by Sunil Shankar Matkar


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