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.

Read also: Biocon Biologics expands biosimilar insulin portfolio with USFDA nod of Kirsty

Further expanding its diabetes portfolio, In June, Biocon received approval in India for its Liraglutide drug substance, and its wholly owned subsidiary, Biocon Pharma Limited, received approval for its Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge), from the Drugs Controller General of India, CDSCO (Central Drugs Standard Control Organisation) in June. The approval was received from the CDSCO under the recently formulated 101 route that enables recognition of approvals granted by established and referenced serious regulatory authorities. Liraglutide is a synthetic analog of GLP-1 peptide and is administered as a once-daily injection.

Read also: CDSCO approves Biocon diabetes drug Liraglutide