Lupin receives USFDA tentative approval for ANDA Drospirenone Tablets

Lupin today announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Drospirenone Tablets, 4 mg, to market a generic equivalent of Slynd Tablets, 4 mg, of Exeltis USA Inc.

Drospirenone Tablets (RLD Slynd) had estimated annual sales of USD 141 million in the U.S. (IQVIA MAT September 2022).

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