Sun Pharmaceutical Industries, an international, integrated, speciality pharmaceutical company announced that the US Food and Drugs Administration (FDA) 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, 25 mg, 50 mg and 100 mg are therapeutic equivalents of Merck Sharp & Dohme Corporation’s Januvia tablets. Sitagliptin tablets have annual sales of approximately US$ 2.7 billion in the US. 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, 500 mg and 1000 mg are therapeutic equivalents of Santarus Inc.’s Glumetza tablets. Metformin HCl Extended-release tablets have annual sales of approximately US$ 140 million in the US. 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.
Januvia is a registered trademark of Merck Sharp & Dohme Corporation and Glumetza is a registered trademark of Santarus Inc.
Sun Pharmaceutical Industries manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.