Lupin gets US FDA approval for Dapagliflozin tablets and Pitavastatin tablets

Lupin announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Dapagliflozin Tablets, 5 mg, and 10 mg to market a generic equivalent of Farxiga Tablets, 5 mg, and 10 mg of AstraZeneca AB. This product will be manufactured at Lupin’s Pithampur facility in India.

Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of $7282 million in the US (IQVIA MAT September 2023).

It has also received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg, to market a generic equivalent of Livalo Tablets, 1 mg, 2 mg, and 4 mg, of Kowa Company. The product will be manufactured at Lupin’s Pithampur facility in India.

Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:

• Adults with primary hyperlipidemia

• Adults and pediatric patients aged eight years and older with heterozygous familial hypercholesterolemia (HeFH)

Pitavastatin Tablets had estimated annual sales of $298 million in the US (IQVIA MAT September 2023)