The approval granted by the US Food and Drug Administration (FDA) for the abbreviated new drug application (ANDA) is for Pregabalin capsules of strengths 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg, the company said in a regulatory filing.
Pharma major Lupin Ltd on Friday said it has received approval from the US health regulator to market its generic version of Pregabalin capsules used for the treatment of pain caused by nerve damage due to diabetes or shingles infection.
The approval granted by the US Food and Drug Administration (FDA) for the abbreviated new drug application (ANDA) is for Pregabalin capsules of strengths 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg, the company said in a regulatory filing.
These are the generic equivalent of Upjohn US 2 LLC’s Lyrica capsules of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg, it added.
The product will be manufactured at Lupin’s facility in Aurangabad, the company said.
Citing IQVIA MAT March 2022 data, Lupin said Pregabalin capsules had estimated annual sales of USD 263 million in the US.
