Sun Pharma at new high on FDA nod for generic version of Januvia

USFDA has granted its subsidiary, two tentative approvals for its ANDA for generic version of Januvia, Sitagliptin tablets and generic version of Glumetza, Metformin HCl extended-release tablets.

Sun Pharmaceutical Industries has moved higher by 3% to Rs 914, extending its previous day’s 2.3% gain after the company said it has received a tentative approval from the US drug regulator for generic version of Januvia.

The stock opened at Rs 886 and hit a new high of Rs 920 on NSE. The trading volumes on the counter more than doubled with a  combined 699,849 shares changing hands till 1141 hours on NSE and BSE.

On Monday, Sun Pharma said that the US Food and Drugs Administration (USFDA) has granted its subsidiary, two tentative approvals for its Abbreviated New Drug Applications (ANDA) for generic version of Januvia, Sitagliptin tablets and generic version of Glumetza, Metformin HCl extended-release tablets.

Sitagliptin tablets have annual sales of approximately US$ 2.7 billion, while Metformin HCl Extended-release tablets have annual sales of approximately US$ 140 million in the US, it added.

Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. Metformin HCl Extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus.