Lupin Gains FDA Approval for Generic Diabetes Medication in the US

Lupin, a prominent pharmaceutical company, announced on January 4 that it has secured approval from the US Food and Drug Administration (USFDA) to market its generic version of a diabetes medication. The approved medication is a combination of Dapagliflozin and Saxagliptin, presented in tablet form, and serves as a generic equivalent to AstraZeneca AB’s Qtern tablets.

The Mumbai-based drug manufacturer revealed this development through a regulatory filing, stating that the approval covers its abbreviated new drug application for the said diabetes treatment. Lupin plans to produce this generic product at its Pithampur facility, reinforcing its commitment to providing cost-effective alternatives in the pharmaceutical market.

According to data from IQVIA, the estimated annual sales of Dapagliflozin and Saxagliptin tablets, the newly approved generic medication, in the US market amounted to USD 5 million. This approval signifies Lupin’s continued efforts to expand its product portfolio and contribute to making essential medications more accessible for patients dealing with diabetes.