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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