Lupin receives USFDA approval for Pregabalin Capsules

Lupin announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg to market a generic equivalent of Lyrica Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg of Upjohn US 2 LLC. The product will be manufactured at Lupin's facility in Aurangabad, India.

Pregabalin Capsules (RLD Lyrica) had estimated annual sales of USD 263 million in the U.S. (IQVIA MAT March 2022).

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