Biocon Pharma bags tentative USFDA nod for diabetes medicine Sitagliptin
Bangalore: Biocon has announced that Biocon Pharma Limited, a wholly-owned subsidiary of the Company, has received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for Sitagliptin Tablets USP, in 25 mg, 50 mg and 100 mg strengths.
Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The approval will further strengthen Biocon’s portfolio of vertically integrated drug products, the company stated in a BSE filing.
In July, another subsidiary, Biocon Biologics Ltd, received approval from the FDA for Kirsty (Insulin Aspart-xjhz), 100 units/mL as the first and only interchangeable biosimilar to NovoLog (Insulin Aspart). KIRSTY is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
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