Sun Pharma gets USFDA approvals for generic Januvia and generic Glumetza

Sun Pharmaceutical Industries has announced that the United States Food & Drug 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 HCI 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 USD 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 HCI extended-release tablets, 500 mg and 1000 mg are therapeutic equivalents of Santarus Inc's Glumetza tablets. Metformin HCI extended-release tablets have annual sales of approximately USD 140 million in the US. Metformin HCI extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus.

 

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